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BOEHRINGER LABORATORIES, LLC

Last updated September 17, 2026

Information

Page 4 of 4

Device	Model / Reference	Registries	Class	Status
Spirometeo & Lung Exerciser, 4601	K771532	FDA 510(k)	Class II	Active
Technicon Sma & Aaii Systems	K770406	FDA 510(k)	Class II	Active
Autowand(tm) 7xxx Series, Modification	K904888	FDA 510(k)	Class II	Active
Regulator, Pressure, Cuff	K760453	FDA 510(k)	Class II	Active
Remote Vacuum Booster System, 7600 Series	K884103	FDA 510(k)	Class II	Active
Boehringer Labs Ambulatory Peep Valve	K800755	FDA 510(k)	Class II	Active
Autotransfusion Reservior Model 7900 Modification	K895297	FDA 510(k)	Class II	Active

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Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Aug 1, 2005	Z-0157-06	—	terminated	Condition exists that prevents complete shutoff of the valve
Aug 1, 2005	Z-0156-06	—	terminated	Condition exists that prevents complete shutoff of the valve
Aug 1, 2005	Z-0155-06	—	terminated	Condition exists that prevents complete shutoff of the valve
May 19, 2004	Z-1232-04	—	terminated	The suction regulator incorporates a gauge for the verification of suction levels. The particular lot of gauges used in the production of the regulators exhibits a potential to develop a leak and cause the delivered suction to be inaccurate.
May 19, 2004	Z-1231-04	—	terminated	The suction regulator incorporates a gauge for the verification of suction levels. The particular lot of gauges used in the production of the regulators exhibits a potential to develop a leak and cause the delivered suction to be inaccurate.
Nov 7, 2003	Z-0227-04	—	terminated	Inadequate bond where the tube attaches to the inlet of the bulb.