Medical Device Manufacturer · US , Mchenry , IL

Instrumentation Industries, Inc.

45 submissions · 44 cleared · Since 1977
45
Total
44
Cleared
0
Denied

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

Instrumentation Industries, Inc. has submitted 45 FDA 510(k) premarket notifications since 1977, of which 44 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Valve, Non-rebreathing, Nebulizer (direct Patient Interface), Ventilator, Emergency, Manual (resuscitator), Cuff, Tracheal Tube, Inflatable, Regulator, Pressure, Gas Cylinder . Use the specialty filter in the sidebar to narrow results.

45 devices
1–25 of 45
NS 120P-TRS Airway Pressure Gauge
K180510 · CAP Monitor, Airway Pressure... · Anesthesiology
May 2019 428d
RTC 26-C Inline Aerosol Adapter
K162753 · CAF Nebulizer (direct Patient... · Anesthesiology
Feb 2017 151d
PILOT TUBE REPAIR KIT
K113644 · BSK Cuff, Tracheal Tube,... · Anesthesiology
Jan 2012 45d
ENDOTRACHEAL TUBE CHANGERS
K102127 · LNZ Changer, Tube, Endotracheal · Anesthesiology
Aug 2010 29d
RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V
K101857 · CAF Nebulizer (direct Patient... · Anesthesiology
Jul 2010 20d
RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI ADAPTER KIT-SINGLE PATIENT USE, MODEL RTC
K091111 · CAF Nebulizer (direct Patient... · Anesthesiology
Dec 2009 229d
NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS
K081778 · CAP Monitor, Airway Pressure... · Anesthesiology
Sep 2008 81d
NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS
K081693 · BXR Meter, Airway Pressure... · Anesthesiology
Sep 2008 86d
METERED DOSE INHALER ADAPTER-DISPOSABLE, ADAPTER REUSABLE
K991355 · CAF Nebulizer (direct Patient... · Anesthesiology
Jan 2000 283d
OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067
K992670 · CBK Ventilator, Continuous,... · Anesthesiology
Sep 1999 88d
MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR
K991785 · BTL Ventilator, Emergency,... · Anesthesiology
Aug 1999 84d
AUTO-PEEP MEASUREMENT DEVICE, MODEL # KC 9-P
K983631 · CBP Valve, Non-rebreathing · Anesthesiology
Jul 1999 259d
METERED DOSE INHALER-REUSABLE MODEL NUMBER RTC 21-A, METERED DOSE INHALER-DISPOSABLE MODEL NUBER RTC 21-D
K981249 · CAF Nebulizer (direct Patient... · Anesthesiology
Nov 1998 231d
EXHALATION VALVE (BE 30-115-B, NS 30-115-U, NS 30-115-5, PS 54-A)
K980725 · CBP Valve, Non-rebreathing · Anesthesiology
Aug 1998 181d
NON-REBREATHING 'T' (BE 117)
K973066 · CBP Valve, Non-rebreathing · Anesthesiology
Feb 1998 169d
PILOT TUBE REPAIR KIT
K973755 · BSK Cuff, Tracheal Tube,... · Anesthesiology
Dec 1997 76d
ONE-WAY VALVE (WITH CONNECTOR)
K970780 · CBP Valve, Non-rebreathing · Anesthesiology
Sep 1997 198d
INSTANT FLOW VAVLE (FLOWMETER, POLE, RAIL, WALL MOUNT)
K970959 · BTM Ventilator, Emergency,... · Anesthesiology
Jun 1997 88d
REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142
K963347 · BYE Attachment, Breathing,... · Anesthesiology
Mar 1997 205d
BE #1100 MOISTURE TRAP & BE #1102/50 DISP CANISTER
K884927 · CAN Regulator, Pressure, Gas... · Anesthesiology
Jun 1989 207d
BE 410 ENDOTRACHEAL TUBE/TRACH TUBE, PILOT REPAIR
K884638 · BSK Cuff, Tracheal Tube,... · Anesthesiology
Nov 1988 16d
BC 1400 HAND POSITIONER
K872316 · KPR System, X-ray, Stationary · Radiology
Aug 1987 56d
BC 1800 FINGER POSITIONER
K872317 · KPR System, X-ray, Stationary · Radiology
Aug 1987 56d
LN 100 BREAST MARKER
K872319 · FTY Tape, Measuring, Rulers... · General & Plastic Surgery
Aug 1987 55d
FOLEY CATHETERS
K863517 · KOD Catheter, Urological · Gastroenterology & Urology
Oct 1986 52d
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