Instrumentation Industries, Incorporated
Bethel Park, PA, US
INSTRUMENTATION INDUSTRIES, INCORPORATED appears in FDA device records in Bethel Park, PA. FDA records list 45 510(k) clearances between and , 3 PMA records and one registered establishment. As of , FDA records show 7 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Instrumentation Industries, Incorporated carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Instrumentation Industries, Inc.510(k), PMA, enforcement report, recall
510(k) clearance history
FDA records hold 45 510(k) clearances for Instrumentation Industries, Incorporated between 1977 and 2019. The busiest year on record is 1977, with 8. The most recent is 2019, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 8 |
| 1981 | 2 |
| 1982 | 5 |
| 1983 | 3 |
| 1986 | 3 |
| 1987 | 3 |
| 1988 | 1 |
| 1989 | 1 |
| 1997 | 4 |
| 1998 | 3 |
| 1999 | 3 |
| 2000 | 1 |
| 2008 | 2 |
| 2009 | 1 |
| 2010 | 2 |
| 2012 | 1 |
| 2017 | 1 |
| 2019 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K180510 | NS 120P-TRS Airway Pressure Gauge | CAP | Substantially Equivalent | |
| K162753 | RTC 26-C Inline Aerosol Adapter | CAF | Substantially Equivalent | |
| K113644 | PILOT TUBE REPAIR KIT | BSK | Substantially Equivalent | |
| K102127 | ENDOTRACHEAL TUBE CHANGERS | LNZ | Substantially Equivalent | |
| K101857 | RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V | CAF | Substantially Equivalent | |
| K091111 | RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI ADAPTER KIT-SINGLE PATIENT USE, MODEL RTC | CAF | Substantially Equivalent | |
| K081778 | NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS | CAP | Substantially Equivalent | |
| K081693 | NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS | BXR | Substantially Equivalent | |
| K991355 | METERED DOSE INHALER ADAPTER-DISPOSABLE, ADAPTER REUSABLE | CAF | Substantially Equivalent | |
| K992670 | OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067 | CBK | Substantially Equivalent - Subject to Tracking Reg. | |
| K991785 | MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR | BTL | Substantially Equivalent | |
| K983631 | AUTO-PEEP MEASUREMENT DEVICE, MODEL # KC 9-P | CBP | Substantially Equivalent | |
| K981249 | METERED DOSE INHALER-REUSABLE MODEL NUMBER RTC 21-A, METERED DOSE INHALER-DISPOSABLE MODEL NUBER RTC 21-D | CAF | Substantially Equivalent | |
| K980725 | EXHALATION VALVE (BE 30-115-B, NS 30-115-U, NS 30-115-5, PS 54-A) | CBP | Substantially Equivalent | |
| K973066 | NON-REBREATHING 'T' (BE 117) | CBP | Substantially Equivalent | |
| K973755 | PILOT TUBE REPAIR KIT | BSK | Substantially Equivalent | |
| K970780 | ONE-WAY VALVE (WITH CONNECTOR) | CBP | Substantially Equivalent | |
| K970959 | INSTANT FLOW VAVLE (FLOWMETER, POLE, RAIL, WALL MOUNT) | BTM | Substantially Equivalent | |
| K963347 | REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142 | BYE | Substantially Equivalent | |
| K884927 | BE #1100 MOISTURE TRAP & BE #1102/50 DISP CANISTER | CAN | Substantially Equivalent | |
| K884638 | BE 410 ENDOTRACHEAL TUBE/TRACH TUBE, PILOT REPAIR | BSK | Substantially Equivalent | |
| K872317 | BC 1800 FINGER POSITIONER | KPR | Substantially Equivalent | |
| K872316 | BC 1400 HAND POSITIONER | KPR | Substantially Equivalent | |
| K872319 | LN 100 BREAST MARKER | FTY | Substantially Equivalent | |
| K863517 | FOLEY CATHETERS | KOD | Substantially Equivalent | |
| K862933 | ABC-1000 SMALL JOINT REAMERS | HTO | Substantially Equivalent | |
| K860077 | SG-066 OXYGEN ENRICHMENT KIT | BTL | Substantially Equivalent | |
| K831486 | SC-603 TWIN VALVE | BTM | Substantially Equivalent | |
| K830475 | BRAIN MODULE RJ-Z10 | CAI | Substantially Equivalent | |
| K830898 | SYRINGE 500BC BE #7000 | BXW | Substantially Equivalent | |
| K823481 | BE #16 - MANIFOLD | BZO | Substantially Equivalent | |
| K823408 | BE#1000-INSTANT ON/OFF O2 VALVE | BTM | Substantially Equivalent | |
| K822831 | RI 300 DIFFERENTIAL TEMPERATURE MONITOR | FLL | Substantially Equivalent | |
| K822608 | MK 808 SERIES NASAL OXYGEN SAMPLER | CCL | Substantially Equivalent | |
| K821492 | BE#6006 VAR. RESIS. INSPIR. MUSCLE | BWF | Substantially Equivalent | |
| K810679 | MS-303-OXYGEN REGULATOR SHIELD | CAN | Substantially Equivalent | |
| K810348 | CM 3 | CBP | Substantially Equivalent | |
| K770633 | BRACKET BE 122-1 | CAF | Substantially Equivalent | |
| K770631 | FLEX ARM BE 122, CLAMP 122-27 | JAY | Substantially Equivalent | |
| K770630 | ADAPTER, UNIVERSAL, BE 105-6 | BZA | Substantially Equivalent | |
| K770629 | VALVE, EXHALATION BE 115-4, 115-5 | CBP | Substantially Equivalent | |
| K770628 | CLAMP BE-152 | JAY | Substantially Equivalent | |
| K770627 | ADAPTER, VALVE, ONE WAY BE-130-22 | CBP | Substantially Equivalent | |
| K770634 | ADAPTER BE 105-101 & 125-101 | BZA | Substantially Equivalent | |
| K770632 | GAS COLLHCTOR BE 155(155-2-3,154-4) | KGK | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2518436 | 2518436 | INSTRUMENTATION INDUSTRIES, INCORPORATED | 2990 INDUSTRIAL BLVD, BETHEL PARK, PA 15102 US | 2026 | and 14 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CAEAirway, Oropharyngeal, Anesthesiology
- CCLAnalyzer, Gas, Oxygen, Gaseous-Phase
- BYEAttachment, Breathing, Positive End Expiratory Pressure
- BTCBag, Reservoir
- BXWCalibrator, Volume, Gas
- KODCatheter, Urological
- LNZChanger, Tube, Endotracheal
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
- BXJClip, Nose
- BZAConnector, Airway (Extension)
- FLLContinuous Measurement Thermometer
- BSKCuff, Tracheal Tube, Inflatable
- BYHDrain, Tee (Water Trap)
- KGKGas, Collecting Vessel
- CCWLaryngoscope, Rigid
- BYGMask, Oxygen
- BXRMeter, Airway Pressure (Inspiratory Force)
- CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)
- BYPMouthpiece, Breathing
- CAFNebulizer (Direct Patient Interface)
- HTOReamer
- CANRegulator, Pressure, Gas Cylinder
- BZOSet, Tubing And Support, Ventilator (W Harness)
- BWFSpirometer, Therapeutic (Incentive)
- JAYSupport, Breathing Tube
- KPRSystem, X-Ray, Stationary
- FTYTape, Measuring, Rulers And Calipers
- BTOTube, Tracheostomy (W/Wo Connector)
- BYXTubing, Pressure And Accessories
- CBPValve, Non-Rebreathing
- CBKVentilator, Continuous, Facility Use
- BTMVentilator, Emergency, Manual (Resuscitator)
- BTLVentilator, Emergency, Powered (Resuscitator)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0269-2016 | Ventilator Tubing | As a distributor of tubing manufactured by Smooth Bore Plastics, we are initiating a product recall for specific lots of KC 036, KC 060 and KC 072 reusable ventilator tubes due to a possible manufacturing defect: A few tubes may have the potential for delamination to occur between the layers of the tube wall which, should it occur, would result in leakage | Class II | Terminated | |
| Z-0606-2014 | 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. | Some packages of the RTC 25-C may have been shipped to customers with incomplete Installation and Usage Directions due to a printing error. | Class II | Terminated | |
| Z-1125-2013 | 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/Inline Filter; and BE 183-R Regulator The BE 183-SUR and BE 183-SU Manual Jet Ventilators are designed to provide transtracheal ventilation in specific emergency situations of upper airway obstructions. | Firm initiated an update to Directions for Use necessitating replacement of previously distributed Directions for Use. | Class II | Terminated | |
| Z-2010-2009 | 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. | user instructions not updated to correspond with product change | Terminated | ||
| Z-0427-06 | Flexible Support Arm Assembly. Breathing Tube Support. Catalog number BE 122-30 | potential for the flexible tube portion of the assembly to become brittle and break | Terminated | ||
| Z-0556-04 | BE 183 Series Manual Jet Ventilators. Manual Jet Ventilator with Regulator and Gauge. | possible external debris in the on/off plunger. | Terminated | ||
| Z-0555-04 | BE 183 Series Manual Jet Ventilators. Manual Jet Ventilator | possible external debris in the on/off plunger. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain