Gish Biomedical, Inc.: FDA clearances and approvals
Gish Biomedical, Inc. has 75 FDA 510(k) clearances (first 1983, latest 2009), across 28 product codes in 6 review panels. Median 510(k) review time: 86 days. openFDA lists 4 product recalls by a recalling firm named Gish Biomedical, Inc.
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 |
|---|---|---|---|
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 16 | 16 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 10 | 10 |
| DQY | Catheter, Percutaneous | 7 | 7 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 6 | 6 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 4 | 4 |
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | 4 | 4 |
| DTP | Defoamer, Cardiopulmonary Bypass | 3 | 3 |
| CAC | Apparatus, Autotransfusion | 2 | 2 |
| DTS | Sucker, Cardiotomy Return, Cardiopulmonary Bypass | 2 | 2 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 2 | 2 |
Plus 18 more product codes.
Review panels
- Cardiovascular (61)
- General Hospital (8)
- General and Plastic Surgery (2)
- Anesthesiology (1)
- Gastroenterology and Urology (1)
- Clinical Toxicology (1)
Most recent Gish Biomedical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K090450 | MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LT | DTZ | 2009-09-18 | 210 |
| K090449 | MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT | DTZ | 2009-09-18 | 210 |
| K091062 | MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730 | DTN | 2009-08-04 | 112 |
| K083131 | MEDOS HILITE RESERVOIR, MODEL: 4030 | DTN | 2009-07-30 | 280 |
| K082403 | MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LT | DTZ | 2009-05-15 | 267 |
| K082082 | GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING | DTN | 2009-02-04 | 196 |
| K081947 | GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING | DTN | 2009-02-04 | 211 |
| K080708 | VISION HOLLOW FIBER OXYGENATOR WITH HA COATING | DTZ | 2009-02-02 | 327 |
| K081838 | GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING | DTR | 2009-01-26 | 210 |
| K081881 | GISH TUBING AND CONNECTORS WITH HA COATING | DWF | 2009-01-23 | 205 |
65 earlier clearances. See the full list in Caduvo.
Recalls
4 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2005-11-28.
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 Gish Biomedical, Inc. have?
Gish Biomedical, Inc. has 75 FDA 510(k) clearances (first 1983, latest 2009), across 28 product codes in 6 review panels.
How long does FDA take to clear Gish Biomedical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Gish Biomedical, Inc.'s cleared 510(k)s is 86 days.
What devices does Gish Biomedical, Inc. make?
Its most frequent FDA product codes are DTN (Reservoir, Blood, Cardiopulmonary Bypass, 16); DTR (Heat-Exchanger, Cardiopulmonary Bypass, 10); DQY (Catheter, Percutaneous, 7).
Has Gish Biomedical, Inc. had device recalls?
openFDA lists 4 product recalls in 4 recall events by a recalling firm whose name matches Gish Biomedical, Inc; the most recent began 2005-11-28. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 75 Gish Biomedical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DTN, Gish Biomedical, 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.