# B.Braun Medical, Inc.

- Location (FDA's records): Allentown, PA
- FDA decisions: 153 (1993–2026): 153 510(k) clearances
- Names in FDA's records: B.Braun Medical, Inc. (151); B. Braun Medical AG (2)
- Product codes: FPA (23), FOZ (12), FRN (11), LHI (9), DYB (9), CAZ (7), FRO (7), FMF (6), BSO (6), BSP (5), FMI (5), LJS (4)
- 510(k) review time since 2016: median 197 days, against 191 for FDA's reviews in the same codes and years (12 of 32 faster)
- Predicates its devices cite: 244 (74 its own); citations of its devices by later devices: 168 (74 its own)
- Recalls linked to its devices: 215 (12 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Advanced Cardiovascular Systems, Inc.: 23 (https://510kreport.com/company/advanced-cardiovascular-systems)
- Burron Medical Products, Inc.: 13 (https://510kreport.com/company/burron-medical-products)
- B. Braun of America, Inc.: 9 (https://510kreport.com/company/b-braun-of-america)
- Bd Becton Dickinson Vacutainer Systems Preanalytic: 7 (https://510kreport.com/company/bd-becton-dickinson-vacutainer-systems-preanalytic)
- Alaris Medical Systems, Inc.: 5 (https://510kreport.com/company/alaris-medical-systems)
- Baxter Healthcare Corp: 5 (https://510kreport.com/company/baxter-healthcare)
- Angeion Corp.: 4 (https://510kreport.com/company/angeion)
- Arrow Intl., Inc.: 3 (https://510kreport.com/company/arrow-intl)

## Firms that cite its devices most
- B. Braun Interventional Systems, Inc.: 4 (https://510kreport.com/company/b-braun-interventional-systems)
- Icu Medical, Inc.: 3 (https://510kreport.com/company/icu-medical)
- PAJUNK GmbH Medizintechnologie: 3 (https://510kreport.com/company/pajunk-medizintechnologie)
- Medline Industries, Inc.: 3 (https://510kreport.com/company/medline-industries)
- B.Braun Melsungen AG: 3 (https://510kreport.com/company/b-braun-melsungen)
- Aesculap, Inc.: 3 (https://510kreport.com/company/aesculap)
- Quest Medical, Inc.: 2 (https://510kreport.com/company/quest-medical)
- Nawa Heilmittel GmbH: 2 (https://510kreport.com/company/nawa-heilmittel)

## Its most-cited devices
- K020785: Introcan Safety IV Catheter (2002), cited by 8
- K955585: V2 Injection Site (1996), cited by 7
- K042488: Perifix Catheter and Contiplex Catheter (2004), cited by 6
- K011975: Horizon Outlook with Dosecom (2001), cited by 5
- K062700: Infusomat Space Volumetric Infusion Pump System (2006), cited by 5
- K072876: Prontosan Wound Irrigation Solution (2008), cited by 5

## Recent decisions
- K260261: Gravity Blood Sets with 200µm Filter (Oct 22, 2026)
- K254111: Irrigation/Urology Sets (Sep 10, 2026)
- K253235: Introcan Safety® Deep Access XL IV Catheter (May 15, 2026)
- K243392: Infusomat® Space Volumetric Infusion Pump Administration Sets (Jul 24, 2025)
- K240578: VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System (Jul 31, 2024)
- K241845: Introcan Safety® 2 IV Catheter (Jul 26, 2024)
- K241385: Omnifix Syringe NRFit (Jul 13, 2024)
- K231242: Perifix FX Catheter; Contiplex FX Catheter (Sep 15, 2023)

Source page: https://510kreport.com/company/b-braun-medical