Medical Device Manufacturer · US , Mchenry , IL

Impact Instrumentation, Inc.

27 submissions · 27 cleared · Since 1981
27
Total
27
Cleared
0
Denied

Impact Instrumentation, Inc. — FDA 510(k) Submissions

Impact Instrumentation, Inc. has submitted 27 FDA 510(k) premarket notifications since 1981, of which 27 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Ventilator, Emergency, Powered (resuscitator), Ventilator, Continuous, Facility Use, Apparatus, Suction, Ward Use, Portable, Ac-powered, Pump, Portable, Aspiration (manual Or Powered), Monitor, Breathing Frequency . Use the specialty filter in the sidebar to narrow results.

27 devices
1–25 of 27
IMPACT MODEL 323 ASPIRATOR
K133196 · JCX Apparatus, Suction, Ward... · General & Plastic Surgery
Mar 2014 144d
UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR
K111473 · CBK Ventilator, Continuous,... · Anesthesiology
Feb 2012 265d
UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR
K103318 · CBK Ventilator, Continuous,... · Anesthesiology
Apr 2011 146d
UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+
K091238 · CBK Ventilator, Continuous,... · Anesthesiology
Aug 2009 108d
UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMV
K071526 · CBK Ventilator, Continuous,... · Anesthesiology
Dec 2008 555d
UNI-VENT MODEL 73X
K051476 · BTL Ventilator, Emergency,... · Anesthesiology
Oct 2005 147d
UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR)
K032386 · BTL Ventilator, Emergency,... · Anesthesiology
Mar 2004 235d
IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00
K022062 · MOD Accessory To Continuous... · Anesthesiology
May 2003 315d
ASPIRATOR, CONTINUOUS & PROGRAMMABLE INTERMITTENT
K951423 · BTA Pump, Portable,... · General & Plastic Surgery
Apr 1995 22d
ELECTRIC VACUM PUMP
K941096 · BTA Pump, Portable,... · General & Plastic Surgery
Jan 1995 304d
IMPACT MODEL 753
K931473 · BTL Ventilator, Emergency,... · Anesthesiology
Dec 1994 646d
POWERED VENTILATOR, LEVER I/II, BATTLEFIELD USE
K905697 · BTL Ventilator, Emergency,... · Anesthesiology
Dec 1990 3d
UNI-VENT(TM) IMPACT MINUTE VOLUME VENTILATOR
K870861 · CBK Ventilator, Continuous,... · Anesthesiology
Jan 1988 322d
IMPACT MODELS 701, 702 AND 703
K861272 · BTL Ventilator, Emergency,... · Anesthesiology
May 1986 46d
IMPACT TURBO CATH
K851611 · JOL Catheter And Tip, Suction · General Hospital
Jun 1985 57d
IMPACT 901 SERIES PORT-A-WALL
K850671 · FOX Stand, Infusion · General Hospital
Mar 1985 19d
IMPACT MODEL 316
K842050 · JCX Apparatus, Suction, Ward... · General & Plastic Surgery
Aug 1984 73d
IMPACT MODEL 308
K841538 · JCX Apparatus, Suction, Ward... · General & Plastic Surgery
Jun 1984 56d
IMPACT MODEL 601
K841537 · BTI Compressor, Air, Portable · Anesthesiology
May 1984 45d
IMPACT, MODEL 310
K820424 · GCX Apparatus, Suction,... · General Hospital
Mar 1982 24d
IMPACT, MODEL 303
K820337 · GCX Apparatus, Suction,... · General Hospital
Mar 1982 22d
IMPACT, MODELS 306/307
K820338 · BTA Pump, Portable,... · General & Plastic Surgery
Mar 1982 22d
IMPACT, MODEL E-12
K820330 · JCX Apparatus, Suction, Ward... · General & Plastic Surgery
Feb 1982 15d
IMPACT, MODEL 302
K820331 · JCX Apparatus, Suction, Ward... · General & Plastic Surgery
Feb 1982 15d
RESPIRATORY SENSOR
K811014 · BZQ Monitor, Breathing Frequency · Anesthesiology
Jun 1981 48d
Filters