Data / Medical devices / United States / Instrumentation Industries, Incorporated

Instrumentation Industries, Incorporated: FDA-registered device maker in Bethel Park, PA, United States, 17 510(k) clearances and 1 PMA approval

Name: Instrumentation Industries, Incorporated FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Instrumentation Industries, Incorporated is registered with the FDA (registration 2518436) in Bethel Park, PA, United States. It lists 24 device types. The FDA files 17 510(k) clearances and 1 PMA approval under its listings, the newest dated May 1, 2019. 6 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 2518436
Address: 2990 Industrial BLVD, Bethel Park, PA, United States, 15102
Owner or operator: INSTRUMENTATION INDUSTRIES, INCORPORATED (2518436)
Roles: Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed: December 30, 1977
Registered through: 2027
Brand names listed: ACU 1060.1, ACU 1060.2, ADP 150, AM 100P, AM MAC Macintosh Laryngoscope Blades, AM MIL Miller Laryngoscope Blades, BB 4500-20D, BE 101-00-1426 and more

Devices it lists

Device	Product code	Class	Role	Source
Airway, Oropharyngeal, Anesthesiology	CAE	1	Repackager or relabeler	accessdata.fda.gov
Attachment, Breathing, Positive End Expiratory Pressure	BYE	2	Manufacturer	accessdata.fda.gov
Bag, Reservoir	BTC	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Changer, Tube, Endotracheal	LNZ	2	Manufacturer	accessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)	CAI	1	Manufacturer	accessdata.fda.gov
Clip, Nose	BXJ	1	Repackager or relabeler	accessdata.fda.gov
Connector, Airway (Extension)	BZA	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Cuff, Tracheal Tube, Inflatable	BSK	2	Manufacturer	accessdata.fda.gov
Drain, Tee (Water Trap)	BYH	1	Manufacturer	accessdata.fda.gov
Laryngoscope, Rigid	CCW	1	Repackager or relabeler	accessdata.fda.gov
Mask, Oxygen	BYG	1	Manufacturer	accessdata.fda.gov
Meter, Airway Pressure (Inspiratory Force)	BXR	2	Manufacturer, Specification developer	accessdata.fda.gov
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	CAP	2	Manufacturer, Specification developer	accessdata.fda.gov
Mouthpiece, Breathing	BYP	1	Manufacturer	accessdata.fda.gov
Nebulizer (Direct Patient Interface)	CAF	2	Manufacturer	accessdata.fda.gov
Set, Tubing And Support, Ventilator (W Harness)	BZO	1	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Support, Breathing Tube	JAY	1	Manufacturer	accessdata.fda.gov
Tape, Measuring, Rulers And Calipers	FTY	1	Manufacturer	accessdata.fda.gov
Tube, Tracheostomy (W/Wo Connector)	BTO	2	Repackager or relabeler	accessdata.fda.gov
Tubing, Pressure And Accessories	BYX	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Valve, Non-Rebreathing	CBP	2	Manufacturer	accessdata.fda.gov
Ventilator, Continuous, Facility Use	CBK	2	Manufacturer	accessdata.fda.gov
Ventilator, Emergency, Manual (Resuscitator)	BTM	2	Manufacturer	accessdata.fda.gov
Ventilator, Emergency, Powered (Resuscitator)	BTL	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 1, 2019	K180510	NS 120P-TRS Airway Pressure Gauge	CAP	Substantially Equivalent	Instrumentation Industries, Inc.	accessdata.fda.gov
February 28, 2017	K162753	RTC 26-C Inline Aerosol Adapter	CAF	Substantially Equivalent	Instrumentation Industries, Inc.	accessdata.fda.gov
July 22, 2010	K101857	RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V	CAF	Substantially Equivalent	Instrumentation Industries, Inc.	accessdata.fda.gov
December 2, 2009	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	Instrumentation Industries, Inc.	accessdata.fda.gov
September 12, 2008	K081778	NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS	CAP	Substantially Equivalent	Instrumentation Industries, Inc.	accessdata.fda.gov
September 11, 2008	K081693	NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS	BXR	Substantially Equivalent	Instrumentation Industries, Inc.	accessdata.fda.gov
January 27, 2000	K991355	METERED DOSE INHALER ADAPTER-DISPOSABLE, ADAPTER REUSABLE	CAF	Substantially Equivalent	Instrumentation Industries, Inc.	accessdata.fda.gov
September 17, 1999	K992670	OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067	CBK	Substantially Equivalent - Subject to Tracking Reg.	Instrumentation Industries, Inc.	accessdata.fda.gov
August 17, 1999	K991785	MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR	BTL	Substantially Equivalent	Instrumentation Industries, Inc.	accessdata.fda.gov
November 23, 1998	K981249	METERED DOSE INHALER-REUSABLE MODEL NUMBER RTC 21-A, METERED DOSE INHALER-DISPOSABLE MODEL NUBER RTC 21-D	CAF	Substantially Equivalent	Instrumentation Industries, Inc.	accessdata.fda.gov
August 24, 1998	K980725	EXHALATION VALVE (BE 30-115-B, NS 30-115-U, NS 30-115-5, PS 54-A)	CBP	Substantially Equivalent	Instrumentation Industries, Inc.	accessdata.fda.gov
February 3, 1998	K973066	NON-REBREATHING 'T' (BE 117)	CBP	Substantially Equivalent	Instrumentation Industries, Inc.	accessdata.fda.gov
December 17, 1997	K973755	PILOT TUBE REPAIR KIT	BSK	Substantially Equivalent	Instrumentation Industries, Inc.	accessdata.fda.gov
September 18, 1997	K970780	ONE-WAY VALVE (WITH CONNECTOR)	CBP	Substantially Equivalent	Instrumentation Industries, Inc.	accessdata.fda.gov
June 13, 1997	K970959	INSTANT FLOW VAVLE (FLOWMETER, POLE, RAIL, WALL MOUNT)	BTM	Substantially Equivalent	Instrumentation Industries, Inc.	accessdata.fda.gov
March 19, 1997	K963347	REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142	BYE	Substantially Equivalent	Instrumentation Industries, Inc.	accessdata.fda.gov
March 19, 1997	K955461	TRANSTRACHEAL CATHETER (ACC. RAVUSSIN).	BTO	Substantially Equivalent	VBM Medizintechnik GmbH	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
July 21, 1981	P800068	ENDOTRACHEAL TUBE CHANGER	LNZ	2	November 4, 1999	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
September 23, 2015	72396	Class II	Terminated	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	accessdata.fda.gov
November 13, 2013	66902	Class II	Terminated	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.	accessdata.fda.gov
September 7, 2012	64568	Class II	Terminated	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	Firm initiated an update to Directions for Use necessitating replacement of previously distributed Directions for Use.	accessdata.fda.gov
July 9, 2009	52898	Not yet classified	Terminated	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	accessdata.fda.gov
October 14, 2005	33923	Not yet classified	Terminated	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	accessdata.fda.gov
September 12, 2003	27419	Not yet classified	Terminated	BE 183 Series Manual Jet Ventilators. Manual Jet Ventilator	possible external debris in the on/off plunger.	accessdata.fda.gov

Compare with other makers

Updated May 1, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.