# Nipro Medical Corporation

- Location (FDA's records): Miami, FL
- FDA decisions: 62 (1997–2026): 62 510(k) clearances
- Names in FDA's records: Nipro Medical Corporation (35); Nipro Medical Corp. (27)
- Product codes: FMF (9), KDI (8), FOZ (8), FMI (7), FIE (6), FPA (5), FIB (3), LIT (2), FJK (2), DQX (2), MEB (1), FMG (1)
- 510(k) review time since 2016: median 246 days, against 119 for FDA's reviews in the same codes and years (2 of 11 faster)
- Predicates its devices cite: 68 (21 its own); citations of its devices by later devices: 43 (21 its own)
- Recalls linked to its devices: 14 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Nissho Corp.: 11 (https://510kreport.com/company/nissho)
- Baxter Healthcare Corp: 6 (https://510kreport.com/company/baxter-healthcare)
- Exel Intl.: 6 (https://510kreport.com/company/exel-intl)
- Terumo Medical Corp.: 3 (https://510kreport.com/company/terumo-medical)
- Medisystems Corp.: 3 (https://510kreport.com/company/medisystems)
- Gainor Medical Europe, Ltd.: 2 (https://510kreport.com/company/gainor-medical-europe)
- Becton, Dickinson & CO: 2 (https://510kreport.com/company/becton-dickinson)
- Fresenius USA, Inc.: 2 (https://510kreport.com/company/fresenius-usa)

## Firms that cite its devices most
- Bain Medical Equipment (Guangzhou) Co., Ltd.: 3 (https://510kreport.com/company/bain-medical-equipment-guangzhou)
- B.Braun Medical, Inc.: 2 (https://510kreport.com/company/b-braun-medical)
- Bioteque Corp.: 2 (https://510kreport.com/company/bioteque)
- Dimesol, Inc.: 2 (https://510kreport.com/company/dimesol)
- Itl Corporation Pty, Ltd.: 1 (https://510kreport.com/company/itl)
- Retractable Technologies, Inc.: 1 (https://510kreport.com/company/retractable-technologies)
- Oxyless, Ltd.: 1 (https://510kreport.com/company/oxyless)
- Wallach Surgical Devices, Inc.: 1 (https://510kreport.com/company/wallach-surgical-devices)

## Its most-cited devices
- K072024: Nipro Blood Tubing Set with Transducer Protector and Priming Set, Model A201-A219, V801-V806, 5M9634, 5M9693 (2007), cited by 6
- K030683: Nipro Disposable Syringes (2003), cited by 4
- K131935: Elisio-H Hemodialyzer, Elisio-M Hemodialyzer (2013), cited by 3
- K051574: Nipro Disposable Syringe with or Without Needle (2005), cited by 3
- K011297: Nipro Safetouch Scalp Vein and Blood Collection Set (2001), cited by 3
- K032777: Modification to: Nipro Safe Touch Safety Fistula Needle (2003), cited by 2

## Recent decisions
- K261399: Elisio™-HX (Jul 28, 2026)
- K253047: Pressone™ (Mar 24, 2026)
- K260533: Elisio™-H (Mar 19, 2026)
- K222852: Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle (May 25, 2023)
- K212677: aboNT SYRINGE (Apr 15, 2022)
- K190037: Cronus HP PTA Balloon Catheter (Oct 24, 2019)
- K191359: Nipro Syringe (Oct 9, 2019)
- K182940: Surdial DX Hemodialysis System (Jul 19, 2019)

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