Cobe Laboratories, Inc.: FDA clearances and approvals
Cobe Laboratories, Inc. has 77 FDA 510(k) clearances (first 1976, latest 1993), across 45 product codes in 6 review panels. Median 510(k) review time: 60 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 |
|---|---|---|---|
| DTZ | Oxygenator, Cardiopulmonary Bypass | 6 | 6 |
| FJI | Dialyzer, Capillary, Hollow Fiber | 6 | 6 |
| FJG | Dialyzer, Parallel Flow | 4 | 4 |
| FKP | System, Dialysate Delivery, Single Patient | 4 | 4 |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 3 | 3 |
| DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 3 | 3 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 3 | 3 |
| CAC | Apparatus, Autotransfusion | 2 | 2 |
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 2 | 2 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 2 | 2 |
Plus 35 more product codes.
Review panels
- Cardiovascular (39)
- Gastroenterology and Urology (31)
- General Hospital (2)
- General and Plastic Surgery (2)
- Anesthesiology (1)
- Hematology (1)
Most recent Cobe Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K923272 | COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATOR | DTZ | 1993-05-11 | 309 |
| K900105 | COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC | LKN | 1991-03-22 | 437 |
| K905793 | COBE CENTRY 2 BICART OPTION KIT | FKP | 1991-02-12 | 47 |
| K905388 | COBE CENTRYSYSTEM 3 BICART OPTION KIT | FKP | 1991-02-11 | 73 |
| K904336 | NEW COBE SATURATION/HEMATOCRIT MONITOR | GKF | 1990-12-27 | 98 |
| K902631 | COBE ICU CONVERSION KIT | DTN | 1990-12-17 | 186 |
| K902437 | COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER | DTP | 1990-12-17 | 196 |
| K904566 | NEW COBE CENTRYSYSTEM(TM) 100 HG DIALYZER | FJI | 1990-12-12 | 64 |
| K902758 | COBE SATURATION/HEMATOCRIT MONITOR W/ FIBER OPTIC | DQA | 1990-08-23 | 59 |
| K902759 | COBE CLOSED WOUND DRAINAGE KIT | CAC | 1990-07-18 | 23 |
67 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Cobe Laboratories, Inc..
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 Cobe Laboratories, Inc. have?
Cobe Laboratories, Inc. has 77 FDA 510(k) clearances (first 1976, latest 1993), across 45 product codes in 6 review panels.
How long does FDA take to clear Cobe Laboratories, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Cobe Laboratories, Inc.'s cleared 510(k)s is 60 days.
What devices does Cobe Laboratories, Inc. make?
Its most frequent FDA product codes are DTZ (Oxygenator, Cardiopulmonary Bypass, 6); FJI (Dialyzer, Capillary, Hollow Fiber, 6); FJG (Dialyzer, Parallel Flow, 4).
Has Cobe Laboratories, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Cobe Laboratories, Inc. Related entities may recall under other names.
Next steps
- See all 77 Cobe Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DTZ, Cobe Laboratories, Inc.'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.