Gambro, Inc.: FDA filings under this applicant name
FDA lists 87 510(k) clearances under the applicant name “Gambro, Inc.” (first 1976, latest 2009), across 38 product codes in 8 review panels. Median 510(k) review time under this name: 44 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 | 15 | 15 |
| FJI | Dialyzer, Capillary, Hollow Fiber | 10 | 10 |
| KOC | Accessories, Blood Circuit, Hemodialysis | 9 | 9 |
| FJG | Dialyzer, Parallel Flow | 7 | 7 |
| FKP | System, Dialysate Delivery, Single Patient | 6 | 6 |
| CBK | Ventilator, Continuous, Facility Use | 2 | 2 |
| DTW | Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass | 2 | 2 |
| DWC | Controller, Temperature, Cardiopulmonary Bypass | 2 | 2 |
| FHS | Dialyzer, Single Coil | 2 | 2 |
| FII | System, Dialysate Delivery, Sealed | 2 | 2 |
Plus 28 more product codes.
Review panels
- Gastroenterology and Urology (65)
- Cardiovascular (11)
- Anesthesiology (5)
- Orthopedic (2)
- Clinical Chemistry (1)
- Dental (1)
- Hematology (1)
- General Hospital (1)
Most recent Gambro, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K083158 | EXALIS, SOFTWARE VERSION 1.15 | KDI | 2009-06-05 | 224 |
| K072093 | PRISMAFLEX SYSTEM, VERSION 3.20 | KDI | 2008-02-01 | 186 |
| K070643 | PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35 | KDI | 2007-11-02 | 239 |
| K032431 | PRISMA M60/M100 SETS | KDI | 2003-09-15 | 40 |
| K896758 | GAMBRO BICARBONATE MONITOR BCM 10-3 | FKP | 1990-09-28 | 301 |
| K896757 | GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWS | FKP | 1990-08-30 | 272 |
| K902481 | GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER | FJI | 1990-07-27 | 52 |
| K900918 | GAMBRO LUNDIA IC-6H PARALLEL PLATE DIALYZER | KDI | 1990-07-16 | 139 |
| K892523 | GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY | FJI | 1989-05-11 | 30 |
| K890112 | ENGSTROM ELIZA + CO2 ANALYZER | CCK | 1989-03-15 | 63 |
77 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Gambro, Inc..
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 Renal Products (37 510(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, Inc.?
FDA lists 87 510(k) clearances under the applicant name “Gambro, Inc.” (first 1976, latest 2009), across 38 product codes in 8 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 Gambro, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Gambro, Inc. is 44 days.
Which FDA product codes appear under Gambro, Inc.?
The most frequent FDA product codes under this applicant name are KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System, 15); FJI (Dialyzer, Capillary, Hollow Fiber, 10); KOC (Accessories, Blood Circuit, Hemodialysis, 9).
Next steps
- See all 87 Gambro, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KDI, Gambro, 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.