Data / Medical devices / United States / Boehringer Laboratories, LLC
Boehringer Laboratories, LLC: FDA-registered device maker in Phoenixville, PA, United States, 4 510(k) clearances
Boehringer Laboratories, LLC is registered with the FDA (registration 2518417) in Phoenixville, PA, United States. It lists 6 device types. The FDA files 4 510(k) clearances under its listings, the newest dated May 6, 2024. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2518417
- Address
- 300 Thoms Drive, Phoenixville, PA, United States, 19460
- Owner or operator
- BOEHRINGER LABORATORIES LLC (2517973)
- Roles
- Manufacturer
- First device listed
- December 29, 1994
- Registered through
- 2026
- Brand names listed
- ARM RESTRAINT STRAPS, Boehringer Suction Regulator, MRI, CareDry Porifem, SUCTION REGULATOR, VISIGI 3D, VOVI Venturi Oxygenation Valve Inlet, ViSiGi, ViSiGi® 3D and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | 2 | Manufacturer | accessdata.fda.gov |
| Collector, Urine, Powered, Non Indwelling Catheter | NZU | 1 | Manufacturer | accessdata.fda.gov |
| Mask, Oxygen, Low Concentration, Venturi | BYF | 1 | Manufacturer | accessdata.fda.gov |
| Regulator, Vacuum | KDP | 2 | Manufacturer | accessdata.fda.gov |
| Restraint, Protective | FMQ | 1 | Manufacturer | accessdata.fda.gov |
| Tubes, Gastrointestinal (And Accessories) | KNT | 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 6, 2024 | K234033 | ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) | KNT | Substantially Equivalent | Boehringer Laboratories, LLC | accessdata.fda.gov |
| January 26, 2024 | K234145 | ViSiGi 3D Gastric Sizing Tube | KNT | Substantially Equivalent | Boehringer Laboratories | accessdata.fda.gov |
| March 28, 2013 | K130483 | BOEHRINGER GASTRIC SIZING TUBE | KNT | Substantially Equivalent | Boehringer Laboratories, LLC | accessdata.fda.gov |
| March 4, 1985 | K850200 | SUCTION REGULATOR 7700 SERIES | KDP | Substantially Equivalent | Boehringer Laboratories | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 1, 2005 | 32810 | Not yet classified | Terminated | Boehringer Suction Regulator Model number 3704 | Condition exists that prevents complete shutoff of the valve | accessdata.fda.gov |
| May 19, 2004 | 29184 | Not yet classified | Terminated | 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. | accessdata.fda.gov |
| November 7, 2003 | 27721 | Not yet classified | Terminated | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Tubes, Gastrointestinal (And Accessories)
- All makers of Collector, Urine, Powered, Non Indwelling Catheter
- All makers of Restraint, Protective
- All makers of Apparatus, Suction, Operating-Room, Wall Vacuum Powered
- All makers of Regulator, Vacuum
- All makers of Mask, Oxygen, Low Concentration, Venturi
Updated May 6, 2024. 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.