# Impact Instrumentation, Inc.

- Location (FDA's records): West Caldwell, NJ
- FDA decisions: 27 (1981–2014): 27 510(k) clearances
- Product codes: CBK (5), BTL (5), JCX (5), BTA (3), BZQ (2), GCX (2), MOD (1), JOL (1), BTI (1), FOX (1), CAP (1)
- Predicates its devices cite: 18 (10 its own); citations of its devices by later devices: 20 (10 its own)
- Recalls linked to its devices: 5 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Airlife, Inc.: 1 (https://510kreport.com/company/airlife)
- Versamed, Ltd.: 1 (https://510kreport.com/company/versamed)
- Pulmonetic Systems, Inc.: 1 (https://510kreport.com/company/pulmonetic-systems)
- Novaspine, LLC: 1 (https://510kreport.com/company/novaspine)
- Sunrise Medical Hhg, Inc.: 1 (https://510kreport.com/company/sunrise-medical-hhg)
- Masimo Corporation: 1 (https://510kreport.com/company/masimo)
- Versamed Medical Systems, Inc.: 1 (https://510kreport.com/company/versamed-medical-systems)
- Bird Products Corp.: 1 (https://510kreport.com/company/bird-products)

## Firms that cite its devices most
- Thornhill Research, Inc.: 3 (https://510kreport.com/company/thornhill-research)
- Automedx, Inc.: 2 (https://510kreport.com/company/automedx)
- ZOLL Medical Corporation: 2 (https://510kreport.com/company/zoll-medical)
- Pneupac, Ltd.: 1 (https://510kreport.com/company/pneupac)
- Moss Medical Products: 1 (https://510kreport.com/company/moss-medical-products)
- Hamilton Medical AG: 1 (https://510kreport.com/company/hamilton-medical)

## Its most-cited devices
- K931473: Impact Model 753 (1994), cited by 6
- K111473: Uni-Vent (R) Model 731 Series Portable Critical Care Ventilator (2012), cited by 2
- K870861: Uni-Vent (TM) Impact Minute Volume Ventilator (1988), cited by 2
- K051476: Uni-Vent Model 73X (2005), cited by 2
- K951423: Aspirator, Continuous & Programmable Intermittent (1995), cited by 2
- K103318: Uni-Vent 731 Series Model Emv+ Portable Critical Care Ventilator (2011), cited by 1

## Recent decisions
- K133196: Impact Model 323 Aspirator (Mar 10, 2014)
- K111473: Uni-Vent (R) Model 731 Series Portable Critical Care Ventilator (Feb 16, 2012)
- K103318: Uni-Vent 731 Series Model Emv+ Portable Critical Care Ventilator (Apr 7, 2011)
- K091238: Uni-Vent-731 Series Ventilators, Model 731EMV+ (Aug 13, 2009)
- K071526: Uni-Vent 731 Series Ventilators, Model 731, 731EMV (Dec 10, 2008)
- K051476: Uni-Vent Model 73X (Oct 28, 2005)
- K032386: Uni-Vent Model 730AEV (Automatic Emergency Ventilator) (Mar 26, 2004)
- K022062: Impact, Universal Single-Limb, Ventilator Circuit, Model 820-0099-00 (May 6, 2003)

Source page: https://510kreport.com/company/impact-instrumentation