Company ยท US
Impact Instrumentation, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 2014. Name variants (Inc, Corp, punctuation) are merged.
27510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | 7 |
| BTL | Ventilator, Emergency, Powered (Resuscitator) | 6 |
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | 6 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 3 |
| BZQ | Monitor, Breathing Frequency | 2 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 2 |
| BTI | Compressor, Air, Portable | 1 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 1 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 1 |
| FOX | Stand, Infusion | 1 |
| JOL | Catheter And Tip, Suction | 1 |
| MOD | Accessory To Continuous Ventilator (Respirator) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 10, 2014 | K133196 | IMPACT MODEL 323 ASPIRATOR Impact Instrumentation, Inc. | JCX |
| Feb 16, 2012 | K111473 | UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR Impact Instrumentation, Inc. | CBK |
| Apr 7, 2011 | K103318 | UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR Impact Instrumentation, Inc. | CBK |
| Aug 13, 2009 | K091238 | UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+ Impact Instrumentation, Inc. | CBK |
| Dec 10, 2008 | K071526 | UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMV Impact Instrumentation, Inc. | CBK |
| Oct 28, 2005 | K051476 | UNI-VENT MODEL 73X Impact Instrumentation, Inc. | BTL |
| Mar 26, 2004 | K032386 | UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR) Impact Instrumentation, Inc. | BTL |
| May 6, 2003 | K022062 | IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00 Impact Instrumentation, Inc. | MOD |
| Apr 18, 1995 | K951423 | ASPIRATOR, CONTINUOUS & PROGRAMMABLE INTERMITTENT Impact Instrumentation, Inc. | BTA |
| Jan 5, 1995 | K941096 | ELECTRIC VACUM PUMP Impact Instrumentation, Inc. | BTA |
| Dec 30, 1994 | K931473 | IMPACT MODEL 753 Impact Instrumentation, Inc. | BTL |
| Dec 27, 1990 | K905697 | POWERED VENTILATOR, LEVER I/II, BATTLEFIELD USE Impact Instrumentation, Inc. | BTL |
| Jan 19, 1988 | K870861 | UNI-VENT(TM) IMPACT MINUTE VOLUME VENTILATOR Impact Instrumentation, Inc. | CBK |
| May 20, 1986 | K861272 | IMPACT MODELS 701, 702 AND 703 Impact Instrumentation, Inc. | BTL |
| Jun 5, 1985 | K851611 | IMPACT TURBO CATH Impact Instrumentation, Inc. | JOL |
| Mar 11, 1985 | K850671 | IMPACT 901 SERIES PORT-A-WALL Impact Instrumentation, Inc. | FOX |
| Aug 3, 1984 | K842050 | IMPACT MODEL 316 Impact Instrumentation, Inc. | JCX |
| Jun 11, 1984 | K841538 | IMPACT MODEL 308 Impact Instrumentation, Inc. | JCX |
| May 31, 1984 | K841537 | IMPACT MODEL 601 Impact Instrumentation, Inc. | BTI |
| Mar 12, 1982 | K820424 | IMPACT, MODEL 310 Impact Instrumentation, Inc. | GCX |
| Mar 2, 1982 | K820338 | IMPACT, MODELS 306/307 Impact Instrumentation, Inc. | BTA |
| Mar 2, 1982 | K820337 | IMPACT, MODEL 303 Impact Instrumentation, Inc. | GCX |
| Feb 23, 1982 | K820331 | IMPACT, MODEL 302 Impact Instrumentation, Inc. | JCX |
| Feb 23, 1982 | K820330 | IMPACT, MODEL E-12 Impact Instrumentation, Inc. | JCX |
| Jun 2, 1981 | K811265 | RESPIRATORY SENSOR (MODEL 409 W/NASOPH.) Impact Instrumentation, Inc. | BZQ |
| Jun 2, 1981 | K811014 | RESPIRATORY SENSOR Impact Instrumentation, Inc. | BZQ |
| Mar 31, 1981 | K810753 | AIRWAY PRESSURE MONITOR Impact Instrumentation, Inc. | CAP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 20, 2012 | Impact Instrumentation, Inc. Model 324JL On-Board Suction System
Intended use: On-board suction system for Ambulance manufacturers. Terminated |
JCX | K820331 |
| Aug 7, 2012 | Impact Instrumentation, Inc. Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell NJ 07006. Indicated for use in the management of acute or chronic respiratory failure or during resuscitation by Terminated |
CBK | K103318 |
| Jan 12, 2012 | Impact Instrumentation, Inc. Model 750 24' MRI Reusable/Disposable Circuit
Accessory for use with Model 750 Portable Ventilator Terminated |
CAI | None listed |
| Nov 4, 2011 | Impact Instrumentation, Inc. Model 73X Uni-Vent
Product Usage: Intended for use at mass casualty incidents. Terminated |
BTL | K051476 |
| Aug 29, 2011 | Impact Instrumentation, Inc. Model 754/754M Disposable MRI Ventilator Circuit
Impact Instrumentation Inc.,
23 Fairfield Place,
West Caldwell, NJ 07006.
Accessory for 700 Series 754/754m Ventilators during MRI examinations Terminated |
CBK | None listed |