Instrumentation Industries Inc

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
45
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0269-2016Class IIVentilator TubingSeptember 23, 2015
Z-0606-2014Class IIRTC 25-C Inline Aerosol Tee Adapter. Intended to be used to adapt an aerosolized medication delivNovember 13, 2013
Z-1125-2013Class IIInstrumentation Industries BE183-SU and BE 183 SU-12 Manual Jet Ventilators; BE 183-SUR and BE 183 SSeptember 7, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K180510NS 120P-TRS Airway Pressure GaugeMay 1, 2019
K162753RTC 26-C Inline Aerosol AdapterFebruary 28, 2017
K113644PILOT TUBE REPAIR KITJanuary 26, 2012
K102127ENDOTRACHEAL TUBE CHANGERSAugust 27, 2010
K101857RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-VJuly 22, 2010
K091111RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI ADAPTER KIT-SINGLE PATDecember 2, 2009
K081778NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORSSeptember 12, 2008
K081693NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERSSeptember 11, 2008
K991355METERED DOSE INHALER ADAPTER-DISPOSABLE, ADAPTER REUSABLEJanuary 27, 2000
K992670OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067September 17, 1999
K991785MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGEAugust 17, 1999
K983631AUTO-PEEP MEASUREMENT DEVICE, MODEL # KC 9-PJuly 1, 1999
K981249METERED DOSE INHALER-REUSABLE MODEL NUMBER RTC 21-A, METERED DOSE INHALER-DISPOSABLE MODEL NUBER RTCNovember 23, 1998
K980725EXHALATION VALVE (BE 30-115-B, NS 30-115-U, NS 30-115-5, PS 54-A)August 24, 1998
K973066NON-REBREATHING 'T' (BE 117)February 3, 1998
K973755PILOT TUBE REPAIR KITDecember 17, 1997
K970780ONE-WAY VALVE (WITH CONNECTOR)September 18, 1997
K970959INSTANT FLOW VAVLE (FLOWMETER, POLE, RAIL, WALL MOUNT)June 13, 1997
K963347REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142March 19, 1997
K884927BE #1100 MOISTURE TRAP & BE #1102/50 DISP CANISTERJune 23, 1989