Althin Medical AB an Affiliate of Baxter Intl: FDA filings under this applicant name
FDA lists 27 510(k) clearances under the applicant name “Althin Medical AB an Affiliate of Baxter Intl” (first 1991, latest 1999), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 184 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 18 | 18 |
| FJI | Dialyzer, Capillary, Hollow Fiber | 6 | 6 |
| MSF | Hemodialyzer, Re-Use, High Flux | 2 | 2 |
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | 1 | 1 |
Review panels
Most recent Althin Medical AB an Affiliate of Baxter Intl 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K990643 | PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015 | KDI | 1999-12-07 | 284 |
| K970681 | ALTRA NOVA 200 HEMODIALYZER | MSF | 1998-07-23 | 514 |
| K970679 | ALTRA FLUX 200 HEMODIALYZER | MSF | 1998-07-23 | 514 |
| K970446 | DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYSTEM | KDI | 1997-06-02 | 117 |
| K964922 | DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM ALTRATOUCH 1000 DIALYSATE DELIVERY SYSTEM | KDI | 1997-05-21 | 163 |
| K955384 | DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM W/SINGLE NEEDLE SINGLE LUMEN OPTION | KDI | 1997-01-10 | 415 |
| K962309 | ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS | FJI | 1996-12-27 | 193 |
| K954987 | ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEM | KDI | 1996-08-08 | 282 |
| K952983 | ALTR NOVA 110 HEMODIALYZER | KDI | 1995-10-05 | 99 |
| K952982 | ALTREX 110 HEMODIALYZER | KDI | 1995-10-05 | 100 |
17 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Althin Medical AB an Affiliate of Baxter Intl.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Althin Medical AB (7 510(k)s)
- Althin Biopharm, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Althin Medical AB an Affiliate of Baxter Intl?
FDA lists 27 510(k) clearances under the applicant name “Althin Medical AB an Affiliate of Baxter Intl” (first 1991, latest 1999), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Althin Medical AB an Affiliate of Baxter Intl?
The median time from FDA receipt to decision across 510(k)s cleared under the name Althin Medical AB an Affiliate of Baxter Intl is 184 days.
Which FDA product codes appear under Althin Medical AB an Affiliate of Baxter Intl?
The most frequent FDA product codes under this applicant name are KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System, 18); FJI (Dialyzer, Capillary, Hollow Fiber, 6); MSF (Hemodialyzer, Re-Use, High Flux, 2).
Next steps
- See all 27 Althin Medical AB an Affiliate of Baxter Intl clearances with predicates and recalls
- Run predicate analysis for product code KDI, Althin Medical AB an Affiliate of Baxter Intl'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.