# Nxstage Medical, Inc.

- Location (FDA's records): Lawrence, MA
- FDA decisions: 51 (2001–2024): 51 510(k) clearances
- Product codes: KDI (26), KPO (6), FKR (5), FKP (4), FJK (2), ODN (2), FLA (1), FIE (1), KOC (1), FIP (1), LGZ (1), FII (1)
- 510(k) review time since 2016: median 135 days, against 188 for FDA's reviews in the same codes and years (3 of 6 faster)
- Predicates its devices cite: 75 (40 its own); citations of its devices by later devices: 46 (40 its own)
- Recalls linked to its devices: 51 (7 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Baxter Healthcare Corp: 4 (https://510kreport.com/company/baxter-healthcare)
- Medisystems Corp.: 3 (https://510kreport.com/company/medisystems)
- Minntech Corp.: 3 (https://510kreport.com/company/minntech)
- Aksys, Ltd.: 2 (https://510kreport.com/company/aksys)
- Gambro, Inc.: 2 (https://510kreport.com/company/gambro)
- Gambro Renal Products: 2 (https://510kreport.com/company/gambro-renal-products)
- Cobe Renal Care, Inc.: 2 (https://510kreport.com/company/cobe-renal-care)
- Fresenius USA, Inc.: 2 (https://510kreport.com/company/fresenius-usa)

## Firms that cite its devices most
- Fresenius Medical Care Renal Therapies Group, LLC: 2 (https://510kreport.com/company/fresenius-medical-care-renal-therapies-group)
- B.Braun Medical, Inc.: 1 (https://510kreport.com/company/b-braun-medical)
- Deka Research and Development: 1 (https://510kreport.com/company/deka-research-and-development)
- Gambro Renal Products: 1 (https://510kreport.com/company/gambro-renal-products)
- Baxter Healthcare Corp: 1 (https://510kreport.com/company/baxter-healthcare)

## Its most-cited devices
- K061837: Nxstage Cartridge Express (2006), cited by 4
- K080807: Blood Tubing Sets (Sterile Fluid Path) (2008), cited by 3
- K141752: Nxstage System One (2014), cited by 3
- K093069: Nxstage System One with Therapeutic Plasma Exchange Cartridge (2010), cited by 2
- K033386: Nxstage Pureflow Solution (2003), cited by 2
- K043436: Nxstage Dialysate Preparation Module, Model NX0269 (2005), cited by 2

## Recent decisions
- K232803: NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) (Mar 14, 2024)
- K233213: NxStage PureFlow Solution (Jan 18, 2024)
- K230632: VersiHD with GuideMe software (Aug 11, 2023)
- K183158: NxStage Cartridge Express with Speedswap (Aug 9, 2019)
- K181991: NxStage Connected Health System (Sep 26, 2018)
- K171331: NxStage System One (Aug 24, 2017)
- K170469: NxStage System One Plus (May 9, 2017)
- K150472: NxStage System One (Jun 4, 2015)

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