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Kinetic Concepts, Inc.

United StatesFDA applicant, unverified

Devices
48
FDA recalls
17

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

Catalogue48

Newest first, rows 1-48 of 48

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  • Cowboy Ii Ref K920308

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Kinair, Low Air Loss Bed Ref K843781

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vacplus Ref K945062

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Modified Pedikair Ref K954320

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Glenn Bed Ref K931581

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Premium Ref K930673

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Turbo Ref K912854

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • V.A.C. Plus Ref K992448

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Hazel Ii Ref K921768

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Trach-Collar Ref K782002

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • V.A.C. Granufoam Silver Dressing Ref K041642

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Profile, A Critical Care Low Air Loss Bed Ref K901901

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cool 'n Heat Machine Ref K891151

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Hazel Ref K912855

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Or Tube Restraint Ref K851874

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Grand Cooling Machine Ref K891152

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ambuvac Ref K971548

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Turbo Ii Ref K933402

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Roto Rest Kinetic Treatment Table Pedia Ref K822402

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • V.A.C. Abdominal Dressing Ref K022011

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Kt Air Bed Ref K970468

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Barikare Plus Ref K945664

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Mini V.A.C., V.A.C. Freedom, V.A.C. Ats Ref K032310

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Sidewinder Omni Wheelchair Direct/Power Ref K823175

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • V.A.C. Instillamat (Vacuum Assisted Closure Instillamat Ref K021501

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Home Care Bead Bed Ref K972176

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Redox Ref K953850

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Annelid Ref K940886

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Omnidirectional Powered Wheel Chair Ref K841542

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Modified Air Fluidized Bed, Kinair Ref K880340

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Wet Chamber Ref K020781

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Cowboy X Ref K944567

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Egerton Turning & Tilting Bed Ref K834563

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • V.A.C. Granufoam Silver Protection Dressing Ref K050261

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Simpulse Ref K972549

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Bariair Ref K955243

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Egerton Turning & Tilting Net Suspen Bed Ref K832845

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Cowboy Iii Ref K932215

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Rotation Air Fluidized Bed/Delta Ref K864232

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Infant Warmer Ref K833802

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vacuum Assisted Closure Ref K021500

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Fluidair Ref K881917

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cowboy Ref K913611

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Modified Rotation Air Fluidized Bed/The Therapulse Ref K875321

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Kinnet Ref K851875

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Triadyne Ref K944094

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Kudo (Powered Rotation Bed) Ref K905390

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Pam Plus Ref K913998

    Active Regimes: 510(k) Registry: 510(k) Class:I

Rows 1-48 of 48

FDA recalls17

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

Showing the 10 most recent of 17 recalls.

  • 2006

    • 17 Mar 2006 Z-0873-06 Unclassified (pre-2012) Terminated Complaints received regarding difficulty opening the nonadherent layer of the device prior to application to open abdominal wounds. Distribution: Product distributed nationwide and to the following countries: Australia, Austria, Belgium, Canada, Denmark, Finland,…
      Full distribution text Product distributed nationwide and to the following countries: Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Norway, Spain, Sweden and Switzerland.
      Submission number: K022011

  • 2005

    • 16 Sep 2005 Z-0379-06 Unclassified (pre-2012) Terminated Possible mislabeling of shipping cartons. Distribution: Product distributed nationwide to hospitals and nursing homes in the following states: AL, AZ, CA, CO, CT, FL, IL, IN,…
      Full distribution text Product distributed nationwide to hospitals and nursing homes in the following states: AL, AZ, CA, CO, CT, FL, IL, IN, KY, MA, NC, NY, OK, PA, SC, and TX.
      Submission number: K032310
    • 24 Jan 2005 Z-0520-06 Unclassified (pre-2012) Terminated To correct software issues in software versions 1.3 and 1.5 and to upgrade hatch latch handles to a more ergonomic design. Distribution: Devices distributed nationwide.

  • 2004

    • 21 Sep 2004 Z-0038-05 Unclassified (pre-2012) Terminated The seal on the dressing pouch may open during shipping and sterility of the dressing may be compromised. Distribution: The product was distributed to hospitals and clinics nationwide. The product was also shipped to the following foreign…
      Full distribution text The product was distributed to hospitals and clinics nationwide. The product was also shipped to the following foreign countries: Australia, Austria, Belgium, Canada, Denmark, France, Germany, Greece, Qatar, Phillipines, United Arab Emirates, Ireland, Italy, Netherlands, South Africa, Spain, Sweden, Switzerland, and United Kingdom.
      Submission number: K032310
    • 16 Aug 2004 Z-0129-06 Unclassified (pre-2012) Terminated Design change to uppgrade reliability of powered adjustable bed. Distribution: Nationwide
    • 22 Mar 2004 Z-0887-04 Unclassified (pre-2012) Terminated Battery outgassing of powered hospital beds Distribution: Product was distributed domestically in the following states: IN, CA, NH, OR, PA, TX, WI, CO, IA, KS, MO, ID, MA, NC,…
      Full distribution text Product was distributed domestically in the following states: IN, CA, NH, OR, PA, TX, WI, CO, IA, KS, MO, ID, MA, NC, IL, OH, MN, AZ, NE, HI, PR, NC
    • 22 Mar 2004 Z-0888-04 Unclassified (pre-2012) Terminated Battery outgassing of powered hospital beds Distribution: Product was distributed domestically in the following states: IN, CA, NH, OR, PA, TX, WI, CO, IA, KS, MO, ID, MA, NC,…
      Full distribution text Product was distributed domestically in the following states: IN, CA, NH, OR, PA, TX, WI, CO, IA, KS, MO, ID, MA, NC, IL, OH, MN, AZ, NE, HI, PR, NC
    • 22 Mar 2004 Z-0889-04 Unclassified (pre-2012) Terminated Battery outgassing of powered hospital beds Distribution: Product was distributed domestically in the following states: IN, CA, NH, OR, PA, TX, WI, CO, IA, KS, MO, ID, MA, NC,…
      Full distribution text Product was distributed domestically in the following states: IN, CA, NH, OR, PA, TX, WI, CO, IA, KS, MO, ID, MA, NC, IL, OH, MN, AZ, NE, HI, PR, NC
    • 22 Mar 2004 Z-0890-04 Unclassified (pre-2012) Terminated Battery outgassing of powered hospital beds Distribution: Product was distributed domestically in the following states: IN, CA, NH, OR, PA, TX, WI, CO, IA, KS, MO, ID, MA, NC,…
      Full distribution text Product was distributed domestically in the following states: IN, CA, NH, OR, PA, TX, WI, CO, IA, KS, MO, ID, MA, NC, IL, OH, MN, AZ, NE, HI, PR, NC

  • 2003

    • 6 Jun 2003 Z-0583-05 Unclassified (pre-2012) Terminated Weld failure causes side rail welds to turn upside down or break off of the bed. Distribution: The beds were distributed nationwide and to Brazil. Submission number: K970468
Show all 17 recalls

  • 2000

    • 11 Apr 2000 Z-0748-03 Unclassified (pre-2012) Terminated Battery Failure/ Outgassing Distribution: Nationwide
    • 11 Apr 2000 Z-0749-03 Unclassified (pre-2012) Terminated Battery Failure/ Outgassing Distribution: Nationwide
    • 11 Apr 2000 Z-0750-03 Unclassified (pre-2012) Terminated Battery Failure/ Outgassing Distribution: Nationwide
    • 11 Apr 2000 Z-0751-03 Unclassified (pre-2012) Terminated Battery Failure/ Outgassing Distribution: Nationwide
    • 11 Apr 2000 Z-0752-03 Unclassified (pre-2012) Terminated Battery Failure/ Outgassing Distribution: Nationwide

  • 1998

    • 21 Oct 1998 Z-0414-03 Unclassified (pre-2012) Terminated Electrical failure of the bed due to fluid egress into the junction box. Distribution: Nationwide Submission number: K955243

  • 1997

    • 1 Jun 1997 Z-0718-03 Unclassified (pre-2012) Terminated Battery out-gassing due to battery over charging and/or secondary failure mode of deep-discharge. Distribution: Nationwide

Frequently asked questions

How many devices does Kinetic Concepts, Inc. have in the registry?

The registry currently lists 48 devices for Kinetic Concepts, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Kinetic Concepts, Inc.'s devices?

Among its 48 most recently registered devices, Kinetic Concepts, Inc. has devices listed in FDA 510(k) (48 devices).

What risk classes do Kinetic Concepts, Inc.'s devices fall under?

Among its 48 most recently registered devices, the classes recorded for Kinetic Concepts, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Kinetic Concepts, Inc.?

FDA recall records list 17 recalls initiated by Kinetic Concepts, Inc., the most recent initiated on 17 Mar 2006. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Kinetic Concepts, Inc. in the registry?

The most recently registered devices listed for Kinetic Concepts, Inc. include COWBOY II, KINAIR, LOW AIR LOSS BED, VACPLUS and MODIFIED PEDIKAIR.

Generated automatically from registry data and not verified by a human reviewer.