Instrumentation Industries Inc
FDA Regulatory Profile
Instrumentation Industries Inc appears in FDA public data with 3 recalls, 45 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0269-2016, Class II) was initiated on September 23, 2015. Its most recent 510(k) clearance was granted on May 1, 2019.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 45
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0269-2016 | Class II | Ventilator Tubing | September 23, 2015 |
| Z-0606-2014 | Class II | RTC 25-C Inline Aerosol Tee Adapter. Intended to be used to adapt an aerosolized medication deliv | November 13, 2013 |
| Z-1125-2013 | Class II | Instrumentation Industries BE183-SU and BE 183 SU-12 Manual Jet Ventilators; BE 183-SUR and BE 183 S | September 7, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K180510 | NS 120P-TRS Airway Pressure Gauge | May 1, 2019 |
| K162753 | RTC 26-C Inline Aerosol Adapter | February 28, 2017 |
| K113644 | PILOT TUBE REPAIR KIT | January 26, 2012 |
| K102127 | ENDOTRACHEAL TUBE CHANGERS | August 27, 2010 |
| K101857 | RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V | July 22, 2010 |
| K091111 | RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI ADAPTER KIT-SINGLE PAT | December 2, 2009 |
| K081778 | NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS | September 12, 2008 |
| K081693 | NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS | September 11, 2008 |
| K991355 | METERED DOSE INHALER ADAPTER-DISPOSABLE, ADAPTER REUSABLE | January 27, 2000 |
| K992670 | OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067 | September 17, 1999 |
| K991785 | MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE | August 17, 1999 |
| K983631 | AUTO-PEEP MEASUREMENT DEVICE, MODEL # KC 9-P | July 1, 1999 |
| K981249 | METERED DOSE INHALER-REUSABLE MODEL NUMBER RTC 21-A, METERED DOSE INHALER-DISPOSABLE MODEL NUBER RTC | November 23, 1998 |
| K980725 | EXHALATION VALVE (BE 30-115-B, NS 30-115-U, NS 30-115-5, PS 54-A) | August 24, 1998 |
| K973066 | NON-REBREATHING 'T' (BE 117) | February 3, 1998 |
| K973755 | PILOT TUBE REPAIR KIT | December 17, 1997 |
| K970780 | ONE-WAY VALVE (WITH CONNECTOR) | September 18, 1997 |
| K970959 | INSTANT FLOW VAVLE (FLOWMETER, POLE, RAIL, WALL MOUNT) | June 13, 1997 |
| K963347 | REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142 | March 19, 1997 |
| K884927 | BE #1100 MOISTURE TRAP & BE #1102/50 DISP CANISTER | June 23, 1989 |