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Instrumentation Industries, Inc.

United StatesFDA 510(k) applicant, unverified

Devices
45
FDA recalls
7

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Instrumentation Industries, Inc. makes

Instrumentation Industries, Inc. manufactures respiratory therapy accessories, including non-rebreathing masks (e.g., BE 117), endotracheal and tracheostomy tube repair kits (e.g., BE 410), and oxygen enrichment kits (e.g., SG-066, SG-067). The company also produces adapters for inhalers (metered dose and reusable), aerosol delivery systems (e.g., RTC 26-C), and pressure measurement devices (e.g., Auto-PEEP measurement device KC 9-P). Additional products include oxygen regulator shields, gas collection systems, and adjustable PEEP valves for ventilatory support.

The portfolio includes Class I and Class II medical devices, with regulatory submissions recorded under FDA’s 510(k) and PMA pathways. Devices are listed in the U.S. under FDA oversight, and the company operates from its U.S. headquarters.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue45

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FDA recalls7

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

FDA recall records list 7 recalls initiated by Instrumentation Industries, Inc., the earliest on 2003-09-12 and the most recent on 2015-09-23. By recorded status: 7 terminated. The reasons filed fall into these groups: packaging, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2015

    • 23 Sep 2015 Z-0269-2016 Class II Terminated As a distributor of tubing manufactured by Smooth Bore Plastics, we are initiating a product recall for specific lots of KC 036, KC 060 and KC 072 reusable ventilator tubes due to a possible manufacturing defect: A few tubes may have the potential for delamination to occur between the layers of the tube wall which, should it occur, would result in leakage Distribution: Worldwide Distribution - US including PA, FL, GA, WA, OH, CA, KA and Internationally to Canada.

  • 2013

    • 13 Nov 2013 Z-0606-2014 Class II Terminated Some packages of the RTC 25-C may have been shipped to customers with incomplete Installation and Usage Directions due to a printing error. Distribution: Nationwide Distribution.

  • 2012

    • 7 Sep 2012 Z-1125-2013 Class II Terminated Firm initiated an update to Directions for Use necessitating replacement of previously distributed Directions for Use. Distribution: Worldwide Distribution - USA including AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN,…
      Full distribution text Worldwide Distribution - USA including AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV. Shipped internationally to Canada, Ireland, Hong Kong, the Netherlands, New Zealand, and Thailand.
      Submission number: K991785

  • 2009

    • 9 Jul 2009 Z-2010-2009 Unclassified (pre-2012) Terminated user instructions not updated to correspond with product change Distribution: Nationwide Distribution -- AK, AL, AR, CA, CO, FL, GA, IA, ID, IL,IN, MA, MD, ME, MI, MN, NC, ND, NH, NJ, OH, PA, SC,…
      Full distribution text Nationwide Distribution -- AK, AL, AR, CA, CO, FL, GA, IA, ID, IL,IN, MA, MD, ME, MI, MN, NC, ND, NH, NJ, OH, PA, SC, SD, TX, VA and WA.
      Submission number: K955461

  • 2005

    • 14 Oct 2005 Z-0427-06 Unclassified (pre-2012) Terminated potential for the flexible tube portion of the assembly to become brittle and break Distribution: The products were shipped to medical facilities in FL, NY, and WV.

  • 2003

    • 12 Sep 2003 Z-0555-04 Unclassified (pre-2012) Terminated possible external debris in the on/off plunger. Distribution: The products were shipped to medical facilities in CA, FL, GA, NY, OH, OR, TX, and UT. Submission number: K991785
    • 12 Sep 2003 Z-0556-04 Unclassified (pre-2012) Terminated possible external debris in the on/off plunger. Distribution: The products were shipped to medical facilities in CA, FL, GA, NY, OH, OR, TX, and UT.

Frequently asked questions

How many devices does Instrumentation Industries, Inc. have in the registry?

The registry currently lists 45 devices for Instrumentation Industries, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Instrumentation Industries, Inc.'s devices?

Among its 45 most recently registered devices, Instrumentation Industries, Inc. has devices listed in FDA 510(k) (44 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Instrumentation Industries, Inc.'s devices fall under?

Among its 45 most recently registered devices, the classes recorded for Instrumentation Industries, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Instrumentation Industries, Inc.?

FDA recall records list 7 recalls initiated by Instrumentation Industries, Inc., the most recent initiated on 2015-09-23. 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 Instrumentation Industries, Inc. in the registry?

The most recently registered devices listed for Instrumentation Industries, Inc. include NON-REBREATHING 'T' (BE 117), BE 410 ENDOTRACHEAL TUBE/TRACH TUBE, PILOT REPAIR, SG-066 OXYGEN ENRICHMENT KIT and GAS COLLHCTOR BE 155(155-2-3, 154-4).

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