Impact Instrumentation, Inc.
Medical device manufacturer in West Caldwell, NJ.
27510(k) clearances
0PMA approvals
5recalls
Device types
- JCX Apparatus, Suction, Ward Use, Portable… 5
- BTL Ventilator, Emergency, Powered (Resuscitator) 5
- CBK Ventilator, Continuous, Facility Use 5
- BTA Pump, Portable, Aspiration (Manual Or… 3
- BZQ Monitor, Breathing Frequency 2
- GCX Apparatus, Suction, Operating-Room, Wall… 2
- CAP Monitor, Airway Pressure (Includes Gauge… 1
- BTI Compressor, Air, Portable 1
- FOX Stand, Infusion 1
- JOL Catheter And Tip, Suction 1
- MOD Accessory To Continuous Ventilator… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K133196 | Impact Model 323 AspiratorJCX · Traditional | 03/10/2014SE |
| K111473 | Uni-Vent (R) Model 731 Series Portable Critical Care VentilatorCBK · Traditional | 02/16/2012SE |
| K103318 | Uni-Vent 731 Series Model Emv+ Portable Critical Care VentilatorCBK · Traditional | 04/07/2011SE |
| K091238 | UNI-VENT-731 Series Ventilators, Model 731EMV+CBK · Traditional | 08/13/2009SE |
| K071526 | Uni-Vent 731 Series Ventilators, Model 731, 731EMVCBK · Traditional | 12/10/2008SE |
| K051476 | Uni-Vent Model 73XBTL · Traditional | 10/28/2005SE |
| K032386 | Uni-Vent Model 730AEV (Automatic Emergency Ventilator)BTL · Traditional | 03/26/2004SE |
| K022062 | Impact, Universal Single-Limb, Ventilator Circuit, Model 820-0099-00MOD · Abbreviated | 05/06/2003SE |
| K951423 | Aspirator, Continuous & Programmable IntermittentBTA · Traditional | 04/18/1995SE |
| K941096 | Electric Vacum PumpBTA · Traditional | 01/05/1995SE |
| K931473 | Impact Model 753BTL · Traditional | 12/30/1994SE |
| K905697 | Powered Ventilator, Lever I/Ii, Battlefield UseBTL · Traditional | 12/27/1990SE |
| K870861 | Uni-Vent(Tm) Impact Minute Volume VentilatorCBK · Traditional | 01/19/1988SE |
| K861272 | Impact Models 701, 702 and 703BTL · Traditional | 05/20/1986SE |
| K851611 | Impact Turbo CathJOL · Traditional | 06/05/1985SE |
| K850671 | Impact 901 Series Port-A-WallFOX · Traditional | 03/11/1985SE |
| K842050 | Impact Model 316JCX · Traditional | 08/03/1984SE |
| K841538 | Impact Model 308JCX · Traditional | 06/11/1984SE |
| K841537 | Impact Model 601BTI · Traditional | 05/31/1984SE |
| K820424 | Impact, Model 310GCX · Traditional | 03/12/1982SE |
| K820338 | Impact, Models 306/307BTA · Traditional | 03/02/1982SE |
| K820337 | Impact, Model 303GCX · Traditional | 03/02/1982SE |
| K820331 | Impact, Model 302JCX · Traditional | 02/23/1982SE |
| K820330 | Impact, Model E-12JCX · Traditional | 02/23/1982SE |
| K811265 | Respiratory Sensor (Model 409 W/Nasoph.)BZQ · Traditional | 06/02/1981SE |
| K811014 | Respiratory SensorBZQ · Traditional | 06/02/1981SE |
| K810753 | Airway Pressure MonitorCAP · Traditional | 03/31/1981SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2430-2012 Class III | Model 324JL On-Board Suction System Intended use: On-board suction system for Ambulance…A shipment mix-up took place. | 03/30/2012Terminated |
| Z-2152-2012 Class III | Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell…Ten units of Model EMV+ Devices were shipped out in error before the verification and validation was… | 03/19/2012Terminated |
| Z-0870-2012 | Model 73X Uni-Vent Product Usage: Intended for use at mass casualty incidents.A piece of internal tubing in the 73X portable ventilator is of incorrect specifications for the device. | 11/04/2011Terminated |
| Z-0717-2012 | Model 750 24' MRI Reusable/Disposable Circuit Accessory for use with Model 750 Portable…Model 750 24' MRI Reusable/Disposable Circuit does not have a 510(k). | 10/19/2011Terminated |
| Z-3080-2011 | Model 754/754M Disposable MRI Ventilator Circuit Impact Instrumentation Inc., 23…Model 754/754 M Disposable MRI Ventilator Circuits are being distributed without market clearence (510k). | 05/27/2011Terminated |