Nxstage Medical, Inc.: FDA filings under this applicant name
FDA lists 51 510(k) clearances under the applicant name “Nxstage Medical, Inc.” (first 2001, latest 2024), across 12 product codes in 2 review panels. Median 510(k) review time under this name: 108 days. Since 2017 the median was 112 days, against 209 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Fresenius Medical Care, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 437 |
| 2013 | 5 | 139 |
| 2014 | 7 | 104 |
| 2015 | 2 | 111 |
| 2016 | 0 | — |
| 2017 | 2 | 95 |
| 2018 | 1 | 62 |
| 2019 | 1 | 267 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 157 |
| 2024 | 2 | 148 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Nxstage Medical, Inc. took a median 112 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 209 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 26 | 26 |
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | 6 | 6 |
| FKR | Subsystem, Proportioning | 5 | 5 |
| FKP | System, Dialysate Delivery, Single Patient | 4 | 4 |
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | 2 | 2 |
| ODN | Ultrafiltration-Controlled Nocturnal Dialysate Delivery System | 2 | 2 |
| FIE | Needle, Fistula | 1 | 1 |
| FII | System, Dialysate Delivery, Sealed | 1 | 1 |
| FIP | Subsystem, Water Purification | 1 | 1 |
| FLA | Monitor, Temperature, Dialysis | 1 | 1 |
Plus 2 more product codes.
Review panels
Most recent Nxstage Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232803 | NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) | KDI | 2024-03-14 | 184 |
| K233213 | NxStage PureFlow Solution | KPO | 2024-01-18 | 112 |
| K230632 | VersiHD with GuideMe software | KDI | 2023-08-11 | 157 |
| K183158 | NxStage Cartridge Express with Speedswap | KDI | 2019-08-09 | 267 |
| K181991 | NxStage Connected Health System | FKP | 2018-09-26 | 62 |
| K171331 | NxStage System One | KDI | 2017-08-24 | 108 |
| K170469 | NxStage System One Plus | KDI | 2017-05-09 | 82 |
| K150472 | NxStage System One | ODN | 2015-06-04 | 101 |
| K143313 | NxStage Therapeutic Plasma Exchange (TPE) Cartridge | KDI | 2015-03-20 | 121 |
| K141752 | NXSTAGE SYSTEM ONE | ODN | 2014-12-19 | 172 |
41 earlier clearances. See the full list in Caduvo.
Recalls
36 product recalls in 16 recall events; 2 initiated in the last five years. Most recent: 2025-04-28.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Nxstage Medical, Inc.?
FDA lists 51 510(k) clearances under the applicant name “Nxstage Medical, Inc.” (first 2001, latest 2024), across 12 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Nxstage Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nxstage Medical, Inc. is 108 days. Since 2017: 112 days, versus 209 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Nxstage Medical, Inc.?
The most frequent FDA product codes under this applicant name are KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System, 26); KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder), 6); FKR (Subsystem, Proportioning, 5).
Next steps
- See all 51 Nxstage Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KDI, Nxstage Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.