Gambro Healthcare: FDA clearances and approvals
Gambro Healthcare has 13 FDA 510(k) clearances (first 1996, latest 2000), across 6 product codes in 3 review panels. Median 510(k) review time: 256 days.
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 | 7 | 7 |
| FIP | Subsystem, Water Purification | 2 | 2 |
| FKT | System, Dialysate Delivery, Sorbent Regenerated | 1 | 1 |
| KMF | Bandage, Liquid | 1 | 1 |
| LFP | Conductivity Rate, Urea Nitrogen | 1 | 1 |
| MSF | Hemodialyzer, Re-Use, High Flux | 1 | 1 |
Review panels
Most recent Gambro Healthcare 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K994390 | GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER | MSF | 2000-10-26 | 303 |
| K990039 | GAMBRO DQM 200 | LFP | 2000-01-27 | 386 |
| K982413 | COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS | KDI | 1999-04-21 | 282 |
| K982414 | GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS | KDI | 1999-03-26 | 256 |
| K980386 | HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100 KITS B22 (B22,B22/B, & B22/0) | KDI | 1999-02-24 | 387 |
| K982760 | COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET | KDI | 1998-11-04 | 90 |
| K982818 | HOSPAL TIPSTOP | KMF | 1998-10-21 | 71 |
| K974899 | GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO H | FIP | 1998-09-23 | 267 |
| K981681 | PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) | KDI | 1998-08-11 | 90 |
| K981085 | GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM | FIP | 1998-05-18 | 54 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Gambro Healthcare.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Gambro Healthcare have?
Gambro Healthcare has 13 FDA 510(k) clearances (first 1996, latest 2000), across 6 product codes in 3 review panels.
How long does FDA take to clear Gambro Healthcare's 510(k)s?
The median time from FDA receipt to decision across Gambro Healthcare's cleared 510(k)s is 256 days.
What devices does Gambro Healthcare make?
Its most frequent FDA product codes are KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System, 7); FIP (Subsystem, Water Purification, 2); FKT (System, Dialysate Delivery, Sorbent Regenerated, 1).
Has Gambro Healthcare had device recalls?
openFDA lists no recalls under a recalling firm name matching Gambro Healthcare. Related entities may recall under other names.
Next steps
- See all 13 Gambro Healthcare clearances with predicates and recalls
- Run predicate analysis for product code KDI, Gambro Healthcare's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.