Althin Medical AB: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Althin Medical AB” (first 1999, latest 2000), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 169 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 | 4 | 4 |
| FJI | Dialyzer, Capillary, Hollow Fiber | 2 | 2 |
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | 1 | 1 |
Review panels
Most recent Althin Medical AB 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K992573 | AF-220 HEMODIALYZER | KDI | 2000-01-18 | 169 |
| K992566 | AF-150 HEMODIALYZER | KDI | 2000-01-18 | 169 |
| K992564 | AF-180 HEMODIALYZER | KDI | 2000-01-18 | 169 |
| K992563 | A-22 HEMODIALYZER | KDI | 2000-01-18 | 169 |
| K992594 | A-15 HEMODIALYZER | FJI | 1999-09-24 | 52 |
| K992565 | A-18 HEMODIALYZER | FJI | 1999-09-23 | 52 |
| K990010 | ALTHIN MEDICAL AB ALTRACART II | KPO | 1999-04-15 | 101 |
Recalls
openFDA lists no recalls under a recalling firm named Althin Medical AB.
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 an Affiliate of Baxter Intl (27 510(k)s)
- Althin Biopharm, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Althin Medical AB?
FDA lists 7 510(k) clearances under the applicant name “Althin Medical AB” (first 1999, latest 2000), across 3 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?
The median time from FDA receipt to decision across 510(k)s cleared under the name Althin Medical AB is 169 days.
Which FDA product codes appear under Althin Medical AB?
The most frequent FDA product codes under this applicant name are KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System, 4); FJI (Dialyzer, Capillary, Hollow Fiber, 2); KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder), 1).
Next steps
- See all 7 Althin Medical AB clearances with predicates and recalls
- Run predicate analysis for product code KDI, Althin Medical AB'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.