Boehringer Laboratories, LLC
Phoenixville, PA, US
BOEHRINGER LABORATORIES, LLC appears in FDA device records in Phoenixville, PA. FDA records list 44 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 6 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 44 510(k) clearances for Boehringer Laboratories, LLC between 1976 and 2026. The busiest year on record is 1994, with 4. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 2 |
| 1977 | 2 |
| 1979 | 3 |
| 1980 | 1 |
| 1983 | 2 |
| 1985 | 3 |
| 1986 | 3 |
| 1988 | 2 |
| 1989 | 1 |
| 1990 | 3 |
| 1991 | 2 |
| 1993 | 2 |
| 1994 | 4 |
| 1995 | 1 |
| 1996 | 1 |
| 2002 | 3 |
| 2006 | 2 |
| 2013 | 1 |
| 2015 | 2 |
| 2024 | 2 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261890 | 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D® | KNT | Substantially Equivalent | |
| K243399 | Boehringer Laboratories Liver Retractor | GCJ | Substantially Equivalent | |
| K234033 | ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) | KNT | Substantially Equivalent | |
| K234145 | ViSiGi 3D Gastric Sizing Tube | KNT | Substantially Equivalent | |
| K151990 | Tissue Removal System | GCJ | Substantially Equivalent | |
| K150781 | Tissue Removal Pouch | GCJ | Substantially Equivalent | |
| K130483 | BOEHRINGER GASTRIC SIZING TUBE | KNT | Substantially Equivalent | |
| K061788 | BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM | OMP | Substantially Equivalent | |
| K060277 | BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM | JCX | Substantially Equivalent | |
| K020538 | BOEHRINGER LABORATORIES PNEUMATIC AMBULATORY COMPRESSION SYSTEM 8200 SERIES | DWL | Substantially Equivalent | |
| K014187 | AUTOVAC ORTHOPEDIC AUTOTRANSFUSION SYSTEM | CAC | Substantially Equivalent | |
| K013976 | BOEHRINGER MRI SUCTION REGULATORY | KDP | Substantially Equivalent | |
| K955010 | AUTOVAC BP SYSTE, 2000 SERIES | CAC | Substantially Equivalent | |
| K945775 | BOEHRINGER AUTOVAC(R) 7900 SERIES | CAC | Substantially Equivalent | |
| K932093 | AUTOVAC CLOSED WOUND AUTOTRANSFUSION SYSTEM,7920 S | CAC | Substantially Equivalent | |
| K933232 | BOEHRINGER LABORATORIES SUCTION REGULATOR, MODIFIED | KDP | Substantially Equivalent | |
| K930615 | AUTOVAC CLOSED WOUND SUCTION SYSTEM | GCY | Substantially Equivalent | |
| K934390 | OSCILLATING BONE SAW BLADE, 6200 SERIES | GFA | Substantially Equivalent | |
| K924894 | AUTOVAC 7900 SERIES | CAC | Substantially Equivalent | |
| K924953 | FLUID COOLED BONE SAW BLADE, 6000 SERIES | GFA | Substantially Equivalent | |
| K904164 | AUTOVAC (R) AUTOTRANSFUSION SYSTEM, 7900 MODIFIED | CAC | Substantially Equivalent | |
| K904888 | AUTOWAND(TM) 7XXX SERIES, MODIFICATION | CAC | Substantially Equivalent | |
| K902059 | AUTOWAND(TM) 7XXX SERIES | CAC | Substantially Equivalent | |
| K901138 | AUTOVAC(R) AUTOTRANSFUSION SYSTEM, 7900 SERIES | CAC | Substantially Equivalent | |
| K895297 | AUTOTRANSFUSION RESERVIOR MODEL 7900 MODIFICATION | CAC | Substantially Equivalent | |
| K884103 | REMOTE VACUUM BOOSTER SYSTEM, 7600 SERIES | GCX | Substantially Equivalent | |
| K881129 | AUTO-VAC INTRAOPERATIVE AUTOTRANS. RESERVOIR #7904 | CAC | Substantially Equivalent | |
| K873521 | BRONCHODILATOR TEE - 9056 SERIES | CAF | Substantially Equivalent | |
| K862684 | AUTO-VAC (TM) AUTOTRANSFUSION RESERV, MODEL 7900 | CAC | Substantially Equivalent | |
| K861025 | T-VAC PLEURAL DRAINAGE UNIT, 7800 SERIES | KDQ | Substantially Equivalent | |
| K855074 | FILTERED VACUUM SAFETY TRAP BOTTLE | KDQ | Substantially Equivalent | |
| K853155 | BOEHRINGER LAB SUCTION INTERRUPTER | KDP | Substantially Equivalent | |
| K853095 | BOEHRINGER LABORATORIES SUCTION INTERMITTOR | GCX | Substantially Equivalent | |
| K850200 | SUCTION REGULATOR 7700 SERIES | KDP | Substantially Equivalent | |
| K832868 | RESUSCITATION VALVE | CBP | Substantially Equivalent | |
| K822689 | PORTABLE MONITORING & SCREENING SPIROM. | BZK | Substantially Equivalent | |
| K800755 | BOEHRINGER LABS AMBULATORY PEEP VALVE | BYE | Substantially Equivalent | |
| K792155 | CO 2 METER | CCK | Substantially Equivalent | |
| K790248 | NICOTINAMIDE-ADENINE AINUCLEOTIDE (NAD) | CFJ | Substantially Equivalent | |
| K782145 | SPIROMETER, MINI POSITIVE | BZK | Substantially Equivalent | |
| K771532 | SPIROMETEO & LUNG EXERCISER, 4601 | BWF | Substantially Equivalent | |
| K770406 | TECHNICON SMA & AAII SYSTEMS | CJE | Substantially Equivalent | |
| K760971 | POSITIVE DISPLACEMENT SPIROMETER | BZK | Substantially Equivalent | |
| K760453 | REGULATOR, PRESSURE, CUFF | JOH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2518417 | 2518417 | BOEHRINGER LABORATORIES, LLC | 300 Thoms Drive, Phoenixville, PA 19460 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- CACApparatus, Autotransfusion
- GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered
- JCXApparatus, Suction, Ward Use, Portable, Ac-Powered
- BYEAttachment, Breathing, Positive End Expiratory Pressure
- GFABlade, Saw, General & Plastic Surgery, Surgical
- KDQBottle, Collection, Vacuum
- NZUCollector, Urine, Powered, Non Indwelling Catheter
- GCJLaparoscope, General & Plastic Surgery
- BYFMask, Oxygen, Low Concentration, Venturi
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CAFNebulizer (Direct Patient Interface)
- OMPNegative Pressure Wound Therapy Powered Suction Pump
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- KDPRegulator, Vacuum
- FMQRestraint, Protective
- BZKSpirometer, Monitoring (W/Wo Alarm)
- BWFSpirometer, Therapeutic (Incentive)
- DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)
- JOHTube Tracheostomy And Tube Cuff
- KNTTubes, Gastrointestinal (And Accessories)
- CBPValve, Non-Rebreathing
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0157-06 | Boehringer Suction Regulator Model number 3714 | Condition exists that prevents complete shutoff of the valve | Terminated | ||
| Z-0156-06 | Boehringer Suction Regulator Model number 3704D3 | Condition exists that prevents complete shutoff of the valve | Terminated | ||
| Z-0155-06 | Boehringer Suction Regulator Model number 3704 | Condition exists that prevents complete shutoff of the valve | Terminated | ||
| Z-1232-04 | Boehringer Replacement Gauge Model 9071, Lot Number 200405. | 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. | Terminated | ||
| Z-1231-04 | Boheringer Suction Regulator Model 7702L, Lot number 04D Boehinger Replacement Gauge, Model 9071, Lot number 200405. | 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. | Terminated | ||
| Z-0227-04 | Autovac TL. Autotransfusion System for Orthopedic Wound Drainage. The product is shipped in cartons containing 6 units | Inadequate bond where the tube attaches to the inlet of the bulb. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain