Company ยท US
Instrumentation Industries, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 2019. Name variants (Inc, Corp, punctuation) are merged.
45510(k) clearances (0 in 12 months)
7recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CBP | Valve, Non-Rebreathing | 7 |
| CAF | Nebulizer (Direct Patient Interface) | 6 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 5 |
| BSK | Cuff, Tracheal Tube, Inflatable | 3 |
| BTL | Ventilator, Emergency, Powered (Resuscitator) | 3 |
| JAY | Support, Breathing Tube | 3 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 2 |
| BZA | Connector, Airway (Extension) | 2 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 2 |
| CAN | Regulator, Pressure, Gas Cylinder | 2 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 2 |
| KPR | System, X-Ray, Stationary | 2 |
| BWF | Spirometer, Therapeutic (Incentive) | 1 |
| BXR | Meter, Airway Pressure (Inspiratory Force) | 1 |
| BXW | Calibrator, Volume, Gas | 1 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 1 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 1 |
| CBK | Ventilator, Continuous, Facility Use | 1 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 1 |
| FLL | Continuous Measurement Thermometer | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 1, 2019 | K180510 | NS 120P-TRS Airway Pressure Gauge Instrumentation Industries, Inc. | CAP |
| Feb 28, 2017 | K162753 | RTC 26-C Inline Aerosol Adapter Instrumentation Industries, Inc. | CAF |
| Jan 26, 2012 | K113644 | PILOT TUBE REPAIR KIT Instrumentation Industries, Inc. | BSK |
| Aug 27, 2010 | K102127 | ENDOTRACHEAL TUBE CHANGERS Instrumentation Industries, Inc. | LNZ |
| Jul 22, 2010 | K101857 | RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V Instrumentation Industries, Inc. | CAF |
| Dec 2, 2009 | K091111 | RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI ADAPTER KIT-SINGLE PATIENT USE, MODEL RTC Instrumentation Industries, Inc. | CAF |
| Sep 12, 2008 | K081778 | NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS Instrumentation Industries, Inc. | CAP |
| Sep 11, 2008 | K081693 | NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS Instrumentation Industries, Inc. | BXR |
| Jan 27, 2000 | K991355 | METERED DOSE INHALER ADAPTER-DISPOSABLE, ADAPTER REUSABLE Instrumentation Industries, Inc. | CAF |
| Sep 17, 1999 | K992670 | OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067 Instrumentation Industries, Inc. | CBK |
| Aug 17, 1999 | K991785 | MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR Instrumentation Industries, Inc. | BTL |
| Jul 1, 1999 | K983631 | AUTO-PEEP MEASUREMENT DEVICE, MODEL # KC 9-P Instrumentation Industries, Inc. | CBP |
| Nov 23, 1998 | K981249 | METERED DOSE INHALER-REUSABLE MODEL NUMBER RTC 21-A, METERED DOSE INHALER-DISPOSABLE MODEL NUBER RTC 21-D Instrumentation Industries, Inc. | CAF |
| Aug 24, 1998 | K980725 | EXHALATION VALVE (BE 30-115-B, NS 30-115-U, NS 30-115-5, PS 54-A) Instrumentation Industries, Inc. | CBP |
| Feb 3, 1998 | K973066 | NON-REBREATHING 'T' (BE 117) Instrumentation Industries, Inc. | CBP |
| Dec 17, 1997 | K973755 | PILOT TUBE REPAIR KIT Instrumentation Industries, Inc. | BSK |
| Sep 18, 1997 | K970780 | ONE-WAY VALVE (WITH CONNECTOR) Instrumentation Industries, Inc. | CBP |
| Jun 13, 1997 | K970959 | INSTANT FLOW VAVLE (FLOWMETER, POLE, RAIL, WALL MOUNT) Instrumentation Industries, Inc. | BTM |
| Mar 19, 1997 | K963347 | REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142 Instrumentation Industries, Inc. | BYE |
| Jun 23, 1989 | K884927 | BE #1100 MOISTURE TRAP & BE #1102/50 DISP CANISTER Instrumentation Industries, Inc. | CAN |
| Nov 23, 1988 | K884638 | BE 410 ENDOTRACHEAL TUBE/TRACH TUBE, PILOT REPAIR Instrumentation Industries, Inc. | BSK |
| Aug 12, 1987 | K872317 | BC 1800 FINGER POSITIONER Instrumentation Industries, Inc. | KPR |
| Aug 12, 1987 | K872316 | BC 1400 HAND POSITIONER Instrumentation Industries, Inc. | KPR |
| Aug 11, 1987 | K872319 | LN 100 BREAST MARKER Instrumentation Industries, Inc. | FTY |
| Oct 31, 1986 | K863517 | FOLEY CATHETERS Instrumentation Industries, Inc. | KOD |
| Aug 18, 1986 | K862933 | ABC-1000 SMALL JOINT REAMERS Instrumentation Industries, Inc. | HTO |
| Feb 18, 1986 | K860077 | SG-066 OXYGEN ENRICHMENT KIT Instrumentation Industries, Inc. | BTL |
| Aug 12, 1983 | K831486 | SC-603 TWIN VALVE Instrumentation Industries, Inc. | BTM |
| Jun 8, 1983 | K830475 | BRAIN MODULE RJ-Z10 Instrumentation Industries, Inc. | CAI |
| May 16, 1983 | K830898 | SYRINGE 500BC BE #7000 Instrumentation Industries, Inc. | BXW |
| Dec 22, 1982 | K823481 | BE #16 - MANIFOLD Instrumentation Industries, Inc. | BZO |
| Dec 7, 1982 | K823408 | BE#1000-INSTANT ON/OFF O2 VALVE Instrumentation Industries, Inc. | BTM |
| Oct 28, 1982 | K822831 | RI 300 DIFFERENTIAL TEMPERATURE MONITOR Instrumentation Industries, Inc. | FLL |
| Oct 4, 1982 | K822608 | MK 808 SERIES NASAL OXYGEN SAMPLER Instrumentation Industries, Inc. | CCL |
| Sep 24, 1982 | K821492 | BE#6006 VAR. RESIS. INSPIR. MUSCLE Instrumentation Industries, Inc. | BWF |
| Apr 17, 1981 | K810679 | MS-303-OXYGEN REGULATOR SHIELD Instrumentation Industries, Inc. | CAN |
| Feb 23, 1981 | K810348 | CM 3 Instrumentation Industries, Inc. | CBP |
| May 23, 1977 | K770633 | BRACKET BE 122-1 Instrumentation Industries, Inc. | CAF |
| May 23, 1977 | K770631 | FLEX ARM BE 122, CLAMP 122-27 Instrumentation Industries, Inc. | JAY |
| May 23, 1977 | K770630 | ADAPTER, UNIVERSAL, BE 105-6 Instrumentation Industries, Inc. | BZA |
| May 23, 1977 | K770629 | VALVE, EXHALATION BE 115-4, 115-5 Instrumentation Industries, Inc. | CBP |
| May 23, 1977 | K770628 | CLAMP BE-152 Instrumentation Industries, Inc. | JAY |
| May 23, 1977 | K770627 | ADAPTER, VALVE, ONE WAY BE-130-22 Instrumentation Industries, Inc. | CBP |
| Apr 8, 1977 | K770634 | ADAPTER BE 105-101 & 125-101 Instrumentation Industries, Inc. | BZA |
| Apr 8, 1977 | K770632 | GAS COLLHCTOR BE 155(155-2-3,154-4) Instrumentation Industries, Inc. | KGK |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 23, 2015 | Instrumentation Industries Inc Ventilator Tubing Terminated |
BTO | None listed |
| Dec 29, 2013 | Instrumentation Industries Inc RTC 25-C Inline Aerosol Tee Adapter.
Intended to be used to adapt an aerosolized medication delivery system having an elliptical mouthpiece to a ventilator circuit. Terminated |
CAI | None listed |
| Apr 16, 2013 | Instrumentation Industries Inc Instrumentation Industries BE183-SU and BE 183 SU-12 Manual Jet Ventilators; BE 183-SUR and BE 183 SUR-12 Manual Jet Ventilators with Regulator and Gauge; BE 183-2 4 ft. Small Bore Tubing Assembly w/I Terminated |
BTL | K991785 |
| Sep 3, 2009 | Instrumentation Industries Inc Transtracheal (Jet Ventilation) Catheter ACU 1060.1, labeled sterile if unopened.
The Jet Ventilation Catheter allows a safe and atraumatic transtracheal access for oxygenation/ventilation. Terminated |
BTO | K955461 |
| Jan 24, 2006 | Instrumentation Industries Inc Flexible Support Arm Assembly. Breathing Tube Support. Catalog number BE 122-30 Terminated |
JAY | None listed |
| Feb 27, 2004 | Instrumentation Industries Inc BE 183 Series Manual Jet Ventilators. Manual Jet Ventilator with Regulator and Gauge. Terminated |
BTM | None listed |
| Feb 27, 2004 | Instrumentation Industries Inc BE 183 Series Manual Jet Ventilators. Manual Jet Ventilator Terminated |
BTM | K991785 |