# Baxter Healthcare Corp

- Location (FDA's records): Round Lake, IL
- FDA decisions: 574 (1977–2025): 568 510(k) clearances, 1 De Novo grant and 5 original PMA approvals
- Names in FDA's records: Baxter Healthcare Corp (507); Baxter Healthcare Corporation (64); Baxter Healthcare (3)
- Product codes: FPA (67), FRN (51), KDI (26), KDJ (16), LHI (12), JJY (10), MQV (10), HET (9), FJI (9), FMI (8), KPE (8), MEB (8)
- 510(k) review time since 2016: median 118 days, against 194 for FDA's reviews in the same codes and years (23 of 36 faster)
- Predicates its devices cite: 214 (126 its own); citations of its devices by later devices: 322 (126 its own)
- Recalls linked to its devices: 421 (32 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Travenol Laboratories, S.A.: 12 (https://510kreport.com/company/travenol-laboratories)
- Gambro Renal Products: 8 (https://510kreport.com/company/gambro-renal-products)
- Apatech, Ltd.: 6 (https://510kreport.com/company/apatech)
- Medtronic Sofamor Danek USA, Inc.: 4 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Althin Medical AB an Affiliate of Baxter Intl: 4 (https://510kreport.com/company/althin-medical-ab-an-affiliate-of-baxter-intl)
- Medimop Medical Projects, Ltd.: 3 (https://510kreport.com/company/medimop-medical-projects)
- Baxter Healthcare Corportation: 2 (https://510kreport.com/company/baxter-healthcare-corportation)
- C.R. Bard, Inc.: 2 (https://510kreport.com/company/cr-bard)

## Firms that cite its devices most
- Edwards Lifesciences, LLC: 24 (https://510kreport.com/company/edwards-lifesciences)
- Nipro Medical Corporation: 6 (https://510kreport.com/company/nipro-medical)
- B.Braun Medical, Inc.: 5 (https://510kreport.com/company/b-braun-medical)
- Nxstage Medical, Inc.: 4 (https://510kreport.com/company/nxstage-medical)
- Fresenius Medical Care North America: 4 (https://510kreport.com/company/fresenius-medical-care-north-america)
- Allegiance Healthcare Corp.: 4 (https://510kreport.com/company/allegiance-healthcare)
- American I.V. Products, Inc.: 4 (https://510kreport.com/company/american-iv-products)
- I-Flow Corp.: 3 (https://510kreport.com/company/i-flow)

## Its most-cited devices
- K926138: Carpentier-Edwards Physio Annuloplasty Ring (1993), cited by 7
- K892410: Fogarty (R) Thru-Lumen Embolectomy Catheter (1989), cited by 6
- K923065: Baxter Personal Cycler Autommated Peritoneal Dial (1994), cited by 6
- K923367: Cosgrove Edwards Annuloplasty System, Model 4600 (1993), cited by 6
- K062079: Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210 (2006), cited by 6
- K910270: Premixed Dialysate for Hemodiafiltration (1991), cited by 5

## Recent decisions
- K251745: Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) (Dec 16, 2025)
- K251640: SIGMA Spectrum Infusion Pump with Master Drug Library (Jul 28, 2025)
- K251636: Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) (Jul 28, 2025)
- K243529: Solution Administration Sets (Mar 14, 2025)
- K242339: Intravascular Extension Sets and Accessories (Feb 28, 2025)
- K242390: Novum IQ Syringe Pump (40800BAXUS) (Sep 5, 2024)
- K241564: Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS (Aug 2, 2024)
- K230665: Dose IQ Safety Software (Mar 29, 2024)

Source page: https://510kreport.com/company/baxter-healthcare