Gambro Renal Products: FDA filings under this applicant name
FDA lists 37 510(k) clearances under the applicant name “Gambro Renal Products” (first 2000, latest 2014), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 119 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 | 2 | 256 |
| 2013 | 1 | 115 |
| 2014 | 2 | 160 |
| 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 |
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | 6 | 6 |
| FIP | Subsystem, Water Purification | 3 | 3 |
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | 3 | 3 |
| FLD | Apparatus, Hemoperfusion, Sorbent | 3 | 3 |
| MPB | Catheter, Hemodialysis, Non-Implanted | 2 | 2 |
| FJI | Dialyzer, Capillary, Hollow Fiber | 1 | 1 |
| MSF | Hemodialyzer, Re-Use, High Flux | 1 | 1 |
Review panels
Most recent Gambro Renal Products 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K133807 | MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT | FLD | 2014-03-26 | 100 |
| K131516 | PRISMAFLEX SYSTEM 7.10 | KDI | 2014-01-03 | 220 |
| K130039 | REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER | KDI | 2013-05-02 | 115 |
| K113313 | MOLECULAR ADSORBENT RECIRCULATING(MARS) | FLD | 2012-12-14 | 401 |
| K120333 | PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPY | KPO | 2012-05-25 | 112 |
| K110823 | PRISMAFLEX | KDI | 2011-06-17 | 85 |
| K103832 | PHOENIX HEMODIALYSIS DELIVERY SYSTEM | KDI | 2011-05-20 | 141 |
| K100451 | GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132 | MPB | 2010-12-21 | 307 |
| K100364 | GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520 | FJK | 2010-11-03 | 264 |
| K093608 | GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H | FIP | 2010-07-29 | 251 |
27 earlier clearances. See the full list in Caduvo.
Recalls
12 product recalls in 9 recall events; 0 initiated in the last five years. Most recent: 2014-11-05.
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.
- Gambro, Inc. (87 510(k)s)
- Gambro Healthcare (13 510(k)s)
- Gambro Renal Care Products (2 510(k)s)
- Gambro Bct, Inc. (1 510(k)s)
- Gambro Services, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Gambro Renal Products?
FDA lists 37 510(k) clearances under the applicant name “Gambro Renal Products” (first 2000, latest 2014), across 8 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 Gambro Renal Products?
The median time from FDA receipt to decision across 510(k)s cleared under the name Gambro Renal Products is 119 days.
Which FDA product codes appear under Gambro Renal Products?
The most frequent FDA product codes under this applicant name are KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System, 18); KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder), 6); FIP (Subsystem, Water Purification, 3).
Next steps
- See all 37 Gambro Renal Products clearances with predicates and recalls
- Run predicate analysis for product code KDI, Gambro Renal Products'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.