Impact Instrumentation, Inc.
United StatesFDA applicant, unverified
- Devices
- 27
- FDA recalls
- 5
At a glance
Market reach
- United States
- FDA recalls
What Impact Instrumentation, Inc. makes
Impact Instrumentation, Inc. manufactures mechanical ventilators, including portable and emergency models like the UNI-VENT-731 series and the UNI-VENT 730AEV (Automatic Emergency Ventilator), as well as ventilator circuit adapters such as the Universal Single-Limb Ventilator Circuit (Model 820-0099-00). The company also produces wall-mounted ventilator systems, including the IMPACT 901 Series Port-A-Wall, and various portable ventilator models like the IMPACT 306/307 and IMPACT 310.
The company’s products are regulated under FDA’s 510(k) clearance process, with devices classified as Class I and Class II. These ventilators and accessories are listed in the FDA’s 510(k) registry, reflecting their authorised status under U.S. medical device regulations. The manufacturer is based in the United States.
Catalogue
Search and filter all 27 devicesFDA recalls
FDA recall records list 5 recalls initiated by Impact Instrumentation, Inc., the earliest on 2011-05-27 and the most recent on 2012-03-30. By recorded status: 5 terminated. The reasons filed fall into these groups: 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.
2012
- 30 Mar 2012 Z-2430-2012 Class III Terminated A shipment mix-up took place.
- 19 Mar 2012 Z-2152-2012 Class III Terminated Ten units of Model EMV+ Devices were shipped out in error before the verification and validation was completed for a new integrated circuit (IC) on the CPU PCB.
2011
- 4 Nov 2011 Z-0870-2012 Unclassified (pre-2012) Terminated A piece of internal tubing in the 73X portable ventilator is of incorrect specifications for the device.
- 19 Oct 2011 Z-0717-2012 Unclassified (pre-2012) Terminated Model 750 24' MRI Reusable/Disposable Circuit does not have a 510(k).
- 27 May 2011 Z-3080-2011 Unclassified (pre-2012) Terminated Model 754/754 M Disposable MRI Ventilator Circuits are being distributed without market clearence (510k).
Frequently asked questions
How many devices does Impact Instrumentation, Inc. have in the registry?
The registry currently lists 27 devices for Impact Instrumentation, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Impact Instrumentation, Inc.'s devices?
Among its 27 most recently registered devices, Impact Instrumentation, Inc. has devices listed in FDA 510(k) (27 devices).
What risk classes do Impact Instrumentation, Inc.'s devices fall under?
Among its 27 most recently registered devices, the classes recorded for Impact Instrumentation, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Impact Instrumentation, Inc.?
FDA recall records list 5 recalls initiated by Impact Instrumentation, Inc., the most recent initiated on 30 Mar 2012. 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 Impact Instrumentation, Inc. in the registry?
The most recently registered devices listed for Impact Instrumentation, Inc. include IMPACT, MODELS 306/307, IMPACT, MODEL E-12, IMPACT MODEL 308 and IMPACT MODEL 753.