# B. Braun of America, Inc.

- Location (FDA's records): Bethlehem, PA
- FDA decisions: 19 (1991–2000): 19 510(k) clearances
- Product codes: LHI (3), LJT (3), FPA (2), BSP (2), DQK (1), FMG (1), IZG (1), LRS (1), FIE (1), DYB (1), FPB (1), FCG (1)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 22 (1 its own)
- Recalls linked to its devices: 47 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- B.Braun Medical, Inc.: 1 (https://510kreport.com/company/b-braun-medical)
- Burron Medical Products, Inc.: 1 (https://510kreport.com/company/burron-medical-products)
- Pharmacia Deltec, Inc.: 1 (https://510kreport.com/company/pharmacia-deltec)

## Firms that cite its devices most
- B.Braun Medical, Inc.: 9 (https://510kreport.com/company/b-braun-medical)
- B. Braun Interventional Systems, Inc.: 3 (https://510kreport.com/company/b-braun-interventional-systems)
- Medimop Medical Projects, Ltd.: 1 (https://510kreport.com/company/medimop-medical-projects)
- Sherwood Medical Co.: 1 (https://510kreport.com/company/sherwood-medical)
- Nipro Medical Corporation: 1 (https://510kreport.com/company/nipro-medical)
- Aesculap, Inc.: 1 (https://510kreport.com/company/aesculap)
- Pharmc, LLC: 1 (https://510kreport.com/company/pharmc)
- Cardinal Health, Alaris Products: 1 (https://510kreport.com/company/cardinal-health-alaris-products)

## Its most-cited devices
- K925401: IV Fluid Transfer Pin (1993), cited by 6
- K983794: Chemo Mini Spike Plus (1999), cited by 3
- K932569: Pencil Point Spinal Needle and Tray (1994), cited by 2
- K943181: Dispensing Pin with One-Way Valve (1994), cited by 2
- K993024: Celsite Implantable Port with Valved Catheter (2000), cited by 2
- K932400: Espocan Combined Spinal/Epidural Needle Set & Tray (1993), cited by 2

## Recent decisions
- K993024: Celsite Implantable Port with Valved Catheter (Mar 13, 2000)
- K983794: Chemo Mini Spike Plus (Mar 23, 1999)
- K946170: Comfort-Q Subcutaneous Injection Sets (Nov 3, 1995)
- K945850: Braun Diacan (R) Fistula Needles (Oct 6, 1995)
- K942988: Filtered Extension Sets (Jul 14, 1995)
- K945752: Celsite (TM) Brachial Venous Port (May 31, 1995)
- K945551: Celsite (TM) Dual Venous System (Apr 21, 1995)
- K943770: Low Volume Multiport (Apr 10, 1995)

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