Data / Medical devices / United States / B. Braun Medical Inc.
B. Braun Medical Inc.: FDA-registered device maker in Bethlehem, PA, United States, 84 510(k) clearances
B. Braun Medical Inc. is registered with the FDA (registration 2521402) in Bethlehem, PA, United States. It lists 43 device types. The FDA files 84 510(k) clearances under its listings, the newest dated September 10, 2026. 11 recall events name it as the recalling firm (3 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2521402
- Address
- 824 12th Ave, Bethlehem, PA, United States, 18018
- Owner or operator
- B. BRAUN MEDICAL INC. (9925035)
- Roles
- Specification developer
- First device listed
- August 27, 1992
- Registered through
- 2026
Devices it lists
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 |
|---|---|---|---|---|---|---|
| September 10, 2026 | K254111 | Irrigation/Urology Sets | LJH | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| July 24, 2025 | K243392 | Infusomat® Space Volumetric Infusion Pump Administration Sets | FPA | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| September 15, 2023 | K231242 | Perifix FX Catheter; Contiplex FX Catheter | BSO | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| January 18, 2022 | K212842 | Microvolume Luer Access Device | FPA | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| September 24, 2021 | K202618 | IV Administration Sets | FPA | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| March 19, 2020 | K191658 | IV Sets not made with PVC | FPA | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| August 2, 2018 | K173531 | Lockbox for Perfusor Space PCA Infusion Pump | MRZ | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| June 26, 2018 | K173361 | IV Administration Set | FPA | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| December 22, 2017 | K171584 | B. Braun Tear-Away Introducer Needle | BSO | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| November 7, 2017 | K170595 | IV Administration Sets | FPA | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| April 6, 2016 | K153293 | Extension Set | FPA | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| February 19, 2016 | K151423 | APEX Compounding System Transfer Set | LHI | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| November 12, 2015 | K150800 | Valved Safety Centesis Catheter | GCB | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| December 5, 2014 | K140838 | IV ADMINISTRATION SET WITH HAND PUMP | FPA | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| August 25, 2014 | K142036 | INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETS | FPA | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| June 27, 2014 | K133632 | PERICAN ULTRA | BSP | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| May 7, 2014 | K140311 | CARESITE LUER ACCESS DEVICE | FPA | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| January 24, 2012 | K113059 | CONTIPLEX FX | CAZ | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| June 5, 2009 | K083723 | A6 LUER ACCESS DEVICE | FPA | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| April 27, 2009 | K090905 | ADDEASE 20MM BINARY CONNECTOR WITH 17 GA. NEEDLE | LHI | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| July 18, 2008 | K080807 | BLOOD TUBING SETS (STERILE FLUID PATH) | FJK | Substantially Equivalent | Nxstage Medical, Inc. | accessdata.fda.gov |
| March 12, 2008 | K073538 | DUAL CHAMBER TPN CONTAINER | KPE | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| June 20, 2007 | K063282 | CONTIPLEX STIM CONTINUOUS NERVE BLOCK SET | CAZ | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| November 16, 2005 | K052252 | CONTRAST MEDIA TRANSFER SETS | FPA | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| October 29, 2004 | K041490 | IV ADMINISTRATION SETS WITH ULTRABLOCK UV-RESISTANT TUBING | FPA | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| October 14, 2004 | K041222 | PINNACLE TPN MANAGEMENT SYSTEM TRANSFER SET | LHI | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| August 4, 2004 | K041415 | EVA TPN CONTAINER | KPE | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| August 13, 2003 | K031600 | CONDUCTION CATHETER | FRN | Substantially Equivalent | Micor, Inc. | accessdata.fda.gov |
| August 11, 2003 | K031923 | ULTRASITE VALVE | FPA | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| July 15, 2003 | K030135 | SAFETY INTRODUCER NEEDLE | DYB | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| January 25, 2002 | K013610 | PERIFIX SAFETY EPIDURAL NEEDLES | BSP | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| October 28, 1999 | K991879 | SPRING-WOUND EPIDURAL CATHETER | BSO | Substantially Equivalent | Micor, Inc. | accessdata.fda.gov |
| March 23, 1999 | K983794 | CHEMO MINI SPIKE PLUS | LHI | Substantially Equivalent | B. Braun of America, Inc. | accessdata.fda.gov |
| October 7, 1997 | K972678 | MILLENNIUM CRT INFUSION PUMP AND MILLENNIUM CRT INFUSION PUMP ADMINISTRATION SETS | FRN | Substantially Equivalent | Mcgaw, Inc. | accessdata.fda.gov |
| April 7, 1997 | K970287 | LUMBAR PUNCTURE KIT | FMJ | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| March 12, 1997 | K955179 | CONTRAST MEDIA SET | IZI | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| January 28, 1997 | K964352 | TORQUE DEVICE | DQX | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| September 19, 1996 | K960674 | CONTRAST INJECTION LINES | DXT | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| May 31, 1996 | K961147 | CLOSED FLUID COLLECTION SYSTEM | GBX | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| May 15, 1996 | K955585 | V2 INJECTION SITE | FPA | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| November 21, 1995 | K954123 | LOW PROFILE SAFSITE Y-SITE | FPA | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| July 14, 1995 | K942988 | FILTERED EXTENSION SETS | FPA | Substantially Equivalent | B. Braun of America, Inc. | accessdata.fda.gov |
| June 21, 1995 | K942391 | BRAUN MANIFOLD | DTL | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| April 10, 1995 | K943770 | LOW VOLUME MULTIPORT | FPA | Substantially Equivalent | B. Braun of America, Inc. | accessdata.fda.gov |
| September 29, 1994 | K943181 | DISPENSING PIN WITH ONE-WAY VALVE | LHI | Substantially Equivalent | B. Braun of America, Inc. | accessdata.fda.gov |
| March 7, 1994 | K931377 | SAFELINE SYSTEM IV ADMINISTRATION SETS & COMPONENT | FPA | Substantially Equivalent | Mcgaw, Inc. | accessdata.fda.gov |
| December 13, 1993 | K932400 | ESPOCAN COMBINED SPINAL/EPIDURAL NEEDLE SET & TRAY | BSP | Unknown | B. Braun of America, Inc. | accessdata.fda.gov |
| June 4, 1993 | K922637 | HORIZON PUMP Y-TYPE BLOOD SET | FPA | Substantially Equivalent | Mcgaw, Inc. | accessdata.fda.gov |
| March 3, 1993 | K925401 | IV FLUID TRANSFER PIN | LHI | Substantially Equivalent | B. Braun of America, Inc. | accessdata.fda.gov |
| July 30, 1992 | K921860 | MODIFICATION TO IV SPIKE | FPA | Substantially Equivalent | Mcgaw, Inc. | accessdata.fda.gov |
| February 27, 1992 | K915421 | GUIDEWIRE INTRODUCER SET | DYB | Substantially Equivalent | B. Braun of America, Inc. | accessdata.fda.gov |
| December 18, 1991 | K913661 | MODIFIED VOLUMETRIC INFUSION PUMP | FRN | Substantially Equivalent | Mcgaw, Inc. | accessdata.fda.gov |
| October 17, 1990 | K904518 | VOLUMETRIC INFUSION PUMP | FRN | Substantially Equivalent | Kendall Mcgaw Laboratories, Inc. | accessdata.fda.gov |
| October 3, 1990 | K903809 | PROTECTED NEEDLE WITH OR WITHOUT IV SET | FPA | Substantially Equivalent | Kendall Mcgaw Laboratories, Inc. | accessdata.fda.gov |
| July 19, 1990 | K902409 | BECTON DICKINSON 360 INFUSER (TM) SYSTEM | FRN | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| July 11, 1990 | K900865 | ADD-A-VIAL II BINARY CONNECTOR | LHI | Substantially Equivalent | Kendall Mcgaw Laboratories, Inc. | accessdata.fda.gov |
| April 30, 1990 | K895580 | Y-ADAPTER W/THOUY BORST | DYB | Substantially Equivalent | Angeion Corp. | accessdata.fda.gov |
| November 30, 1989 | K894446 | ANGEION HEMOSTASIS VALVE INTRODUCER | DYB | Substantially Equivalent | Angeion Corp. | accessdata.fda.gov |
| September 27, 1989 | K895109 | SECONDARY IV SET WITH PROTECTED NEEDLE | FPA | Substantially Equivalent | Kendall Mcgaw Laboratories, Inc. | accessdata.fda.gov |
| August 3, 1989 | K884183 | BURRON TEFLON-COATED GUIDEWIRE | DQX | Substantially Equivalent | Burron Medical, Inc. | accessdata.fda.gov |
| June 24, 1987 | K871153 | CATHETER INTRODUCER | DYB | Substantially Equivalent | Angeion Corp. | accessdata.fda.gov |
| September 18, 1985 | K853014 | MCGHAN TISSUE EXPANDER FILL KIT | LCJ | Substantially Equivalent | Mcghan Medical Corp. | accessdata.fda.gov |
| January 28, 1985 | K844719 | 360 INFUSER | FRN | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| August 12, 1984 | K841639 | NOVA BALLOON THERMODILUTION CATH. | DYG | Substantially Equivalent | Nova Medical Specialties | accessdata.fda.gov |
| March 6, 1984 | K840388 | PAB IV CONTAINER | KPE | Substantially Equivalent | American Mcgaw | accessdata.fda.gov |
| March 6, 1984 | K840212 | CONCENTRATED PLATELET ADMIN. SET | FPA | Substantially Equivalent | American Mcgaw | accessdata.fda.gov |
| February 24, 1984 | K840179 | CONTINUOUS EPIDURAL ANESTHES. TRAY | CAZ | Substantially Equivalent | Burron Medical Products, Inc. | accessdata.fda.gov |
| February 23, 1984 | K840287 | BRACHIAL PLEXUS ANESTHESIA TRAY | CAZ | Substantially Equivalent | Burron Medical Products, Inc. | accessdata.fda.gov |
| November 1, 1982 | K822806 | BALLOON WEDGE PRESSURE, ANGIOGRAPHIC | DYG | Substantially Equivalent | Nova Medical Specialties | accessdata.fda.gov |
| March 8, 1982 | K820454 | THE RED CAP | FMF | Substantially Equivalent | Burron Medical Products, Inc. | accessdata.fda.gov |
| March 8, 1982 | K820453 | THE INT-STOPPER | FPA | Substantially Equivalent | Burron Medical Products, Inc. | accessdata.fda.gov |
| December 31, 1981 | K813092 | ACCUPRO I.V. ADMINISTRATION SET | FPA | Substantially Equivalent | American Mcgaw | accessdata.fda.gov |
| March 11, 1981 | K810460 | BURRON PERCUTANEOUS INDUCER SET | DQY | Substantially Equivalent | Burron Medical Products, Inc. | accessdata.fda.gov |
| June 17, 1980 | K801311 | BURRON MULTI-AD SYRINGE CAP | FMF | Substantially Equivalent | Burron Medical Products, Inc. | accessdata.fda.gov |
| May 30, 1980 | K801108 | DOUBLE ENDED VENTED TRANSFER DEVICE | FMI | Substantially Equivalent | Burron Medical Products, Inc. | accessdata.fda.gov |
| May 30, 1980 | K801107 | DOUBLE ENDED FILTERED TRANSFER NEEDLE | FMI | Substantially Equivalent | Burron Medical Products, Inc. | accessdata.fda.gov |
| March 12, 1980 | K800437 | SYRINGE TIP CONNECTOR | KYX | Substantially Equivalent | Burron Medical Products, Inc. | accessdata.fda.gov |
| December 20, 1979 | K792227 | MULTI-AD FLUID DISPENSING SYSTEM | KYX | Substantially Equivalent | National Patent Development Corp. | accessdata.fda.gov |
| April 10, 1979 | K790062 | IV ADMINISTRATION SET WITH BACKCHECK | FPA | Substantially Equivalent | National Patent Development Corp. | accessdata.fda.gov |
| December 7, 1978 | K781744 | IV SET WITH GRADUATED CHAMBER | FPA | Substantially Equivalent | National Patent Development Corp. | accessdata.fda.gov |
| April 19, 1978 | K780551 | I.V. ADMINISTRATION SET WITH MINI-SPIKE | FPA | Substantially Equivalent | National Patent Development Corp. | accessdata.fda.gov |
| November 2, 1976 | K760388 | CATHETER, VEIN (VENOFIX) | DQO | Substantially Equivalent | B. Braun Instruments | accessdata.fda.gov |
| November 2, 1976 | K760385 | EXTENSION SETS | KGZ | Substantially Equivalent | B. Braun Instruments | accessdata.fda.gov |
| November 2, 1976 | K760381 | BLOOD TRANSFUSION SET (SANGOFIX) | JCY | Substantially Equivalent | B. Braun Instruments | 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 14, 2026 | 99879 | Class II | Ongoing | B Braun SAFSITE Injection Site, RV1000NC SAFSITE VALVE W/O EXTRA CAP. Catalog Number: 415068. | Potential for leakage and backflow at the Safsite valve. | accessdata.fda.gov |
| August 4, 2026 | 99550 | Class II | Ongoing | Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Catalog Number: 456025 | Specific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on the carton shipper label. | accessdata.fda.gov |
| May 6, 2026 | 98838 | Class I | Ongoing | Spinal Needle procedure kits: Material Description (Material Number) 24GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333867); 25GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333862); GOVP24BK 24G PENCAN TRAY W/ BUP & DEXTROS (332607 | These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huons Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection. | accessdata.fda.gov |
| March 19, 2026 | 98552 | Class I | Ongoing | B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A. | Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure. | accessdata.fda.gov |
| February 2, 2026 | 98380 | Class II | Ongoing | Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B3050 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temp | The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. | accessdata.fda.gov |
| January 29, 2026 | 98862 | Class II | Ongoing | Brand Name: B. BRAUN MEDICAL INC Product Name: CESK NORTHSIDE ANESTHESIA TRAY Model/Catalog Number: 555076 Software Version: N/A Product Description: CESK NORTHSIDE ANESTHESIA TRAY Component: No | B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable. | accessdata.fda.gov |
| October 29, 2025 | 97816 | Class II | Ongoing | ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding cata | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | accessdata.fda.gov |
| February 17, 2025 | 96293 | Class II | Ongoing | Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter. | Increased risk for valve housing detachment causing leakage. | accessdata.fda.gov |
| August 15, 2024 | 95171 | Class II | Ongoing | SL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095 | Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient connector is not fully inserted into the Locksite, the internal septum may not open fully enough to prevent restrictions to flow. may cause delays | accessdata.fda.gov |
| January 28, 2022 | 89784 | Class II | Terminated | Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (BIC) - VERSION 2, Article Code Number 3456102A. These conductivity sensors may be used as spare parts for the following dialy | Firm learned of the potential for cracks to form in the conductivity sensors during use, which may lead to a leak in the dialysate circuit. This could result in excessive ultrafiltration or insufficient ultrafiltration depending on whether the dialysis machine is equipped with a Dialysis Fluid filter. | accessdata.fda.gov |
| April 1, 2016 | 73744 | Class I | Terminated | Dialog+ Hemodialysis machines: Dialog A + HE/BIC Product Code 710200L Serial # >200318 and < 2039222 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidn | Potential leakage of conductivity sensors of the Dialog Dialysis machines. | accessdata.fda.gov |
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Updated October 16, 2026. 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.