Cobe Renal Care, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Cobe Renal Care, Inc.” (first 1994, latest 1997), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 454 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 | 8 | 8 |
| FJG | Dialyzer, Parallel Flow | 2 | 2 |
| FJI | Dialyzer, Capillary, Hollow Fiber | 2 | 2 |
| KDL | Set, Perfusion, Kidney, Disposable | 1 | 1 |
| MQS | System, Hemodialysis, Access Recirculation Monitoring | 1 | 1 |
Review panels
Most recent Cobe Renal Care, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K955497 | GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET | KDL | 1997-09-25 | 664 |
| K955592 | COBE CENTRYSYSTEM 14 PES HEMODIALYZERS | KDI | 1997-04-30 | 510 |
| K955487 | GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS | KDI | 1997-04-18 | 504 |
| K946279 | PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) | KDI | 1997-02-10 | 776 |
| K954003 | COBE HEMODYNAMIC RECIRCULATION MONITOR | MQS | 1997-02-06 | 531 |
| K960474 | COBE CENTRYSYSTEM 600 HG HEMODIALYZERS | KDI | 1996-08-14 | 194 |
| K944436 | COBE CENTRYSYSTEM CS 200 DIALYZER | FJI | 1996-01-29 | 504 |
| K951311 | GAMBRO HC 14R HEMOCONCENTRATOR | KDI | 1996-01-11 | 295 |
| K952342 | GAMBRO LUNDIA 94-700 & SIGMA 800 HEMODIALYZERS | KDI | 1995-09-15 | 119 |
| K945747 | GAMBRO LUNDIA 94-600 DIALYZER | KDI | 1995-09-08 | 289 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Cobe Renal Care, 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.
- Cobe Laboratories, Inc. (77 510(k)s)
- Cobe Cardiovascular, Inc. (43 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cobe Renal Care, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Cobe Renal Care, Inc.” (first 1994, latest 1997), across 5 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 Cobe Renal Care, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cobe Renal Care, Inc. is 454 days.
Which FDA product codes appear under Cobe Renal Care, Inc.?
The most frequent FDA product codes under this applicant name are KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System, 8); FJG (Dialyzer, Parallel Flow, 2); FJI (Dialyzer, Capillary, Hollow Fiber, 2).
Next steps
- See all 14 Cobe Renal Care, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KDI, Cobe Renal Care, 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.