Data / Medical devices / United States / B. Braun Medical Inc.
B. Braun Medical Inc.: FDA-registered device maker in Allentown, PA, United States, 150 510(k) clearances
B. Braun Medical Inc. is registered with the FDA (registration 3013764800) in Allentown, PA, United States. It lists 62 device types. The FDA files 150 510(k) clearances under its listings, the newest dated September 10, 2026. 3 recall events name it as the recalling firm (2 Class I). Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3013764800
- Address
- 861 Marcon Blvd., Allentown, PA, United States, 18109
- Owner or operator
- B. BRAUN MEDICAL INC. (9925035)
- Roles
- Complaint file establishment
- First device listed
- August 27, 1992
- Registered through
- 2026
- Brand names listed
- B-SMART
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. Newest 100 of 150.
| 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 |
| May 15, 2026 | K253235 | Introcan Safety® Deep Access XL IV Catheter | FOZ | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| August 5, 2025 | K251411 | Chemfort Female Luer Lock Adaptor | ONB | Substantially Equivalent | Simplivia Healthcare , Ltd. | accessdata.fda.gov |
| July 24, 2025 | K243392 | Infusomat® Space Volumetric Infusion Pump Administration Sets | FPA | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| July 31, 2024 | K240578 | VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System | DTK | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| July 26, 2024 | K241845 | Introcan Safety® 2 IV Catheter | FOZ | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| July 13, 2024 | K241385 | Omnifix Syringe NRFit | QEH | 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 |
| August 16, 2023 | K223479 | AQUAbase nX | FIP | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| August 2, 2023 | K231286 | Chemfort® Catheter Adaptor | ONB | Substantially Equivalent | Simplivia Healthcare , Ltd. | accessdata.fda.gov |
| September 15, 2022 | K211204 | SafePort(TM) Manifold (or Stopcock) | FMG | Substantially Equivalent | Elcam Medical Acal | accessdata.fda.gov |
| June 23, 2022 | K220756 | Introcan Safety 2 IV Catheter | FOZ | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| May 14, 2022 | K220626 | Introcan Safety IV Catheter | FOZ | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| February 11, 2022 | K213664 | B. Braun Introcan Safety 2 IV Catheter | FOZ | 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 |
| October 25, 2021 | K213085 | Introcan Safety 3 Closed IV Catheter | FOZ | 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 |
| September 23, 2021 | K210707 | OnGuard2 Chemfort Closed Administration (CADM) | ONB | Substantially Equivalent | Simplivia Healthcare , Ltd. | accessdata.fda.gov |
| February 25, 2021 | K201142 | TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE, TEVADAPTOR Bag Adaptor SP with ULTRASITE, TEVADAPTOR IV Secondary Safety Set with ULTRASITE, TEVADAPTOR IV Secondary Safety set | ONB | Substantially Equivalent | Simplivia Healthcare , Ltd. | accessdata.fda.gov |
| December 9, 2020 | K201469 | Mini Spike Plus 6/8R | LHI | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| June 5, 2020 | K191491 | EZ-Cover | ITX | Substantially Equivalent | Medxpress.Pro | accessdata.fda.gov |
| May 27, 2020 | K192914 | Stimuplex Onvision System | BSP | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| May 7, 2020 | K192866 | Chemfort CSTD | ONB | Substantially Equivalent | Simplivia Healthcare , Ltd. | accessdata.fda.gov |
| March 12, 2020 | K191910 | SpaceStation MRI | MRZ | Substantially Equivalent | B. Braun Melsugen AG | accessdata.fda.gov |
| March 5, 2020 | K193101 | Omnifix Low Dead Space Luer Lock Syringe | FMF | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| April 23, 2019 | K190489 | Elcam Stopcocks and Manifolds | FMG | Substantially Equivalent | Elcam Medical Acal | accessdata.fda.gov |
| September 21, 2018 | K180489 | TEVADAPTOR Closed Drug Reconstitution and Transfer System | ONB | Substantially Equivalent | Teva Medical Ltd., Migada Plant | 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 |
| June 12, 2018 | K172831 | Perfusor® Space Syringe Infusion Pump System | FRN | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| June 11, 2018 | K173803 | Omnican fine | FMI | 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 |
| November 3, 2017 | K170897 | Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site | PTI | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| August 11, 2017 | K170574 | Diacap Pro Dialyzer | KDI | Substantially Equivalent | B. Braun Avitum AG | accessdata.fda.gov |
| May 23, 2017 | K163430 | Prontosan Wound Gel | FRO | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| November 10, 2016 | K161623 | Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL | FRO | 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 |
| March 1, 2016 | K143482 | xevonta dialyzer | KDI | Substantially Equivalent | B. Braun Avitum AG | accessdata.fda.gov |
| February 19, 2016 | K151423 | APEX Compounding System Transfer Set | LHI | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| December 2, 2015 | K150787 | Universal Spike | 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 |
| June 18, 2015 | K142596 | Infusomat Space Volumetric Infusion Pump | FRN | 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 12, 2014 | K141306 | TEVADAPTOR; CONNECTING SET W/ ULTRASITE INJECTION SITE, SPIKE PORT ADAPTOR SET W/ ULTRASITE INJECTION SITE | FPA | Substantially Equivalent | Teva Medical Ltd., Migada Plant | accessdata.fda.gov |
| May 7, 2014 | K140311 | CARESITE LUER ACCESS DEVICE | FPA | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| October 8, 2013 | K130857 | PRONTOSAN WOUND GEL X | FRO | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| August 20, 2013 | K131842 | STERICAN CANNULA | FMI | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| March 25, 2013 | K124059 | AQUABOSS ECORO DIA I (HT); AQUABOSS ECORO DIA II (HT) | FIP | Substantially Equivalent | Lauer Membran Wassertechnik GmbH | accessdata.fda.gov |
| January 22, 2013 | K121269 | TBA | FPA | Substantially Equivalent | Migada Plant | accessdata.fda.gov |
| January 24, 2012 | K113059 | CONTIPLEX FX | CAZ | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| April 25, 2011 | K102194 | SOLCART B | KPO | Substantially Equivalent | B. Braun Avitum AG | accessdata.fda.gov |
| July 29, 2010 | K093489 | IN VISION-PLUS NANO WITH NEUTRAL ADVANTAGE TECHNOLOGY | FPA | Substantially Equivalent | Rymed Technologies, Inc. | accessdata.fda.gov |
| February 18, 2010 | K083460 | DIALOG WITH ADIMEA OPTION | KDI | Substantially Equivalent | B. Braun Avitum AG | accessdata.fda.gov |
| November 4, 2009 | K092313 | PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM | MEA | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| August 14, 2009 | K090995 | B. BRAUN CONTIPLEX CONTINUOUS NERVE BLOCK SET | CAZ | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| July 1, 2009 | K083689 | INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM | FRN | 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 |
| July 15, 2008 | K081905 | ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP | MEB | Substantially Equivalent | Westmed, Inc. | accessdata.fda.gov |
| June 19, 2008 | K072876 | PRONTOSAN WOUND IRRIGATION SOLUTION | FRO | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| March 12, 2008 | K073538 | DUAL CHAMBER TPN CONTAINER | KPE | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| January 29, 2008 | K072760 | SOLCART B | KPO | Substantially Equivalent | B. Braun Medizintechnologie GmbH | accessdata.fda.gov |
| November 8, 2007 | K072247 | STERICAN HYPODERMIC NEEDLES | FMI | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| August 16, 2007 | K071459 | B. BRAUN PISTON SYRINGES AND OMNICAN AND OMNIFIX INSULIN SYRINGES | FMF | 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 |
| March 22, 2007 | K070134 | MODIFICATION TO STIMUPLEX HNS-12, MODEL 4892098 | BXN | Substantially Equivalent | Stockert GmbH | accessdata.fda.gov |
| January 12, 2007 | K063217 | VENATECH LP BRACHIAL INTRODUCER SYSTEM (ANTECUBITAL) | DTK | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| November 17, 2006 | K063280 | INJEKT SYRINGE | FMF | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| October 26, 2006 | K062700 | INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM | FRN | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| October 26, 2006 | K062699 | PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM | FRN | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| June 9, 2006 | K052764 | DIACAP ULTRA DIALYSIS FLUID FILTER | FKQ | Substantially Equivalent | B. Braun Medizintechnologie GmbH | accessdata.fda.gov |
| April 13, 2006 | K060231 | CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK | FMG | Substantially Equivalent | Elcam Medical Acal | accessdata.fda.gov |
| November 17, 2005 | K052313 | STIMUPLEX HNS-12, MODEL 4892098 | BXN | Substantially Equivalent | Stockert GmbH | accessdata.fda.gov |
| November 16, 2005 | K052252 | CONTRAST MEDIA TRANSFER SETS | FPA | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| November 9, 2005 | K052393 | B. BRAUN MODIFIED BICARBONATE DIALYSATE | KPO | 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 27, 2004 | K041683 | B. BRAUN BICARBONATE DIALYSATE | KPO | 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 |
| January 15, 2004 | K031128 | B-SMART, MODEL B-01 | CAZ | Substantially Equivalent | Macosta Medical USA, LLC | 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 |
| October 18, 2002 | K022895 | ELCAM STOPCOCKS AND MANIFOLDS | FMG | Substantially Equivalent | Medical Device Consultants, Inc. | accessdata.fda.gov |
| January 25, 2002 | K013610 | PERIFIX SAFETY EPIDURAL NEEDLES | BSP | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| September 19, 2001 | K011975 | HORIZON OUTLOOK WITH DOSECOM | FRN | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| December 4, 2000 | K003029 | INFUSOMAT P | FRN | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| March 8, 2000 | K994375 | HORIZON LIGHT | FRN | 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 |
| June 24, 1999 | K991653 | INVISION-PLUS INJECTION PORT CONNECTOR SYSTEM | FPA | Substantially Equivalent | Rymed Technologies, Inc. | accessdata.fda.gov |
| March 23, 1999 | K983794 | CHEMO MINI SPIKE PLUS | LHI | Substantially Equivalent | B. Braun of America, Inc. | accessdata.fda.gov |
| June 26, 1998 | K963440 | DIALOG DIALYSIS MACHINE | KDI | Substantially Equivalent | B. Braun Medical AG | accessdata.fda.gov |
| October 17, 1997 | K971233 | SOFT TIP EPIDURAL CATHETER KIT | CAZ | Unknown | B.Braun Medical, Inc. | accessdata.fda.gov |
| April 7, 1997 | K970287 | LUMBAR PUNCTURE KIT | FMJ | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| April 3, 1997 | K962696 | PERIFIX PEDIATRIC EPIDURAL KIT | CAZ | Unknown | B.Braun Medical, Inc. | accessdata.fda.gov |
| March 12, 1997 | K955179 | CONTRAST MEDIA SET | IZI | 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 |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 30, 2025 | 97609 | Class I | Ongoing | Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M2096 Software Version: N/A Product Description: STREAMLINE BLOODLINE SET FOR DIALOG Component: N/A | The potential for micro-air bubbles observed in the bloodline and air-in-line alarms due to damaged arterial and venous patient connectors. | accessdata.fda.gov |
| September 18, 2025 | 97550 | Class II | Ongoing | PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (9cm) Tuohy Epidural Needle - Winged and PERIFIX FX Springwound Catheter - 19 Ga. Closed Tip. Product Code: CE17TBFC. Product description: CE | Potential for the lid of the catheter connector to be in the incorrect position. | accessdata.fda.gov |
| July 9, 2025 | 97167 | Class I | Ongoing | Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing. | Label is incorrect. The product label indicates that the device contains an air eliminating filter. However, the filter utilized on this extension set is not indicated for removal of air and does not feature an air vent, which is common to air eliminating filters. | accessdata.fda.gov |
Compare with other makers
- All makers of Introducer, Catheter
- All makers of Set, Administration, Intravascular
- All makers of Needle, Conduction, Anesthetic (W/Wo Introducer)
- All makers of Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
- All makers of Anesthesia Conduction Kit
- All makers of Filter, Intravascular, Cardiovascular
Updated September 10, 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.