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Circulatory Technology, Inc.

United StatesFDA applicant, unverified

Circulatory Technology, Inc. is a medical device manufacturer, with 11 devices listed in FDA 510(k) and FDA GUDID (FDA Class II and I) and 7 FDA recalls as of 15 Nov 2026.

Devices
11
FDA recalls
71 ongoing

Registry facts

Counted by deviCERTS from registry records, 15 Nov 2026

Registries
  • FDA 510(k) 9
  • FDA GUDID 2

A device listed in two registries counts in both.

Device classes
  • FDA Class II 10
  • FDA Class I 1
FDA recalls
Identifiers
  • DUNS 786778944

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

Catalogue11

Newest first, rows 1-11 of 11

Search and filter all 11 devices
Skip device list

  • Better-Bladder BB14 Open recall

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

  • Bigger Better-Bladder BBB38 Open recall

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

  • The V Bag, Catalog Number VB1800; Vac-Box For Vacuum Assisted Venous Drainage, Catalog Number VACBOX1500 Ref K012942

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

  • Initary Better Bladder-Pediatric Ref K140321

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

  • Better-Tubing Ref K964205

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

  • Better-Bladder (Bb) Ref K981284 Open recall

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

  • Pressure Relief Valve Ref K941492

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

  • The V-Bag Ref K001822

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

  • Better-Venter Ref K961594

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

  • Better-Bladder (Bb) Ref K964337

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

  • Pressure Infusion Cuff Ref K942933

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

Rows 1-11 of 11

Company details

DUNS number
786778944
Phone
+1(516)624-2424

FDA recalls7

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

Recalls initiated per year

  • 2017 2
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 1
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

4 initiated before 2017

  • 2021

    • 27 Apr 2021 Z-1862-2021 Class II Ongoing The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and may collapse during use which can increase resistance to flow in the venous line and cause a drop in circuit blood flow. Distribution: US Nationwide distribution in the states of AL, AR, CA, DC, FL, GA, IN, MO, NC, PA, SC, TX. Submission number: K981284

  • 2017

    • 22 Sep 2017 Z-0817-2018 Class II Terminated The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and may collapse during use which can increase resistance to flow in the venous line and cause a drop in circuit blood flow. Distribution: **Requested update** Distributed in 19 states: AL, AR, CA, FL, GA, IL, IN, KY, MD, MO, NJ, NY, OH, OR, PA, TN, TX, VA,…
      Full distribution text **Requested update** Distributed in 19 states: AL, AR, CA, FL, GA, IL, IN, KY, MD, MO, NJ, NY, OH, OR, PA, TN, TX, VA, WA, and the District of Columbia.
      Submission number: K981284
    • 22 Sep 2017 Z-1171-2018 Class II Terminated The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and may collapse during use which can increase resistance to flow in the venous line and cause a drop in circuit blood flow. Distribution: **Requested update** Distributed in 19 states: AL, AR, CA, FL, GA, IL, IN, KY, MD, MO, NJ, NY, OH, OR, PA, TN, TX, VA,…
      Full distribution text **Requested update** Distributed in 19 states: AL, AR, CA, FL, GA, IL, IN, KY, MD, MO, NJ, NY, OH, OR, PA, TN, TX, VA, WA, and the District of Columbia.
      Submission number: K981284

  • 2016

    • 1 Jul 2016 Z-0057-2017 Class III Terminated Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm. Distribution: US Nationwide Distribution to states of: AL, AR, CA, Washington, D.C., FL, GA, IA, IL, IN, KY, LA, MI, MS, NC, NJ, NY,…
      Full distribution text US Nationwide Distribution to states of: AL, AR, CA, Washington, D.C., FL, GA, IA, IL, IN, KY, LA, MI, MS, NC, NJ, NY, OH, OK, PA, SC, TN, TX & VA.
      Submission number: K981284
    • 1 Jul 2016 Z-2832-2016 Class II Terminated The seal between the balloon and the housing may leak. Distribution: US Distribution to states of: LA, MI, NY, OH, OR & TX. Submission number: K981284
    • 3 Mar 2016 Z-2050-2016 Class II Terminated The seal between the balloon and the housing may leak. Distribution: US Distribution to the states of: CA, IN, MI, NY, PA, TX & VA Submission number: K981284

  • 2009

    • 3 Jun 2009 Z-1323-2010 Unclassified (pre-2012) Terminated During an FDA inspection, it was discovered that the firm had conducted a silent recall of its Bigger Better Bladder device after receiving a complaint from a hospital that the device collapsed during a procedure thereby obstructing flow. Distribution: Arizona, Arkansas, California, Florida, Indiana, Iowa, Maine, Michigan, Nebraska, New York, North Carolina,…
      Full distribution text Arizona, Arkansas, California, Florida, Indiana, Iowa, Maine, Michigan, Nebraska, New York, North Carolina, Pennsylvania, Ohio, Texas, Utah, Washington DC, and Germany.
      Submission number: K981284

Frequently asked questions

How many devices does Circulatory Technology, Inc. have in the registry?

The registry currently lists 11 devices for Circulatory Technology, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Circulatory Technology, Inc.'s devices?

Among its 11 most recently registered devices, Circulatory Technology, Inc. has devices listed in FDA 510(k) (9 devices) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Circulatory Technology, Inc.'s devices fall under?

Among its 11 most recently registered devices, the classes recorded for Circulatory Technology, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Circulatory Technology, Inc.?

FDA recall records list 7 recalls initiated by Circulatory Technology, Inc., the most recent initiated on 27 Apr 2021. 1 of them is recorded as ongoing. 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 Circulatory Technology, Inc. in the registry?

The most recently registered devices listed for Circulatory Technology, Inc. include Better-Bladder BB14, Bigger Better-Bladder BBB38, THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500 and INITARY BETTER BLADDER-PEDIATRIC.

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