FDA product code JOD: Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass
JOD is the FDA product code for filter, blood, cardiotomy suction line, cardiopulmonary bypass. It is a Class II device, regulated under 21 CFR 870.4270 and reviewed by the Cardiovascular panel. FDA has cleared 12 510(k) submissions under JOD, from 7 different applicants. The average 510(k) review took 74 days (median 60).
Classification
| Field | Value |
|---|---|
| Device name | Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass |
| Device class | Class II |
| Regulation | 21 CFR 870.4270 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every JOD clearance
Top JOD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medical, Inc. | 4 | 1982-11-24 |
| Pall Biomedical Products Co. | 2 | 1988-02-29 |
| Cobe Laboratories, Inc. | 2 | 1986-02-26 |
| Olson Medical Sales, Inc. | 1 | 2000-03-28 |
| Gish Biomedical, Inc. | 1 | 1989-03-10 |
2 more applicants have JOD clearances. See the full list in Caduvo.
Most recent JOD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K993060 | Olson Medical Sales, Inc. | GAS FILTER | 2000-03-28 | 197 |
| K890504 | Gish Biomedical, Inc. | CARDIOTOMY/AUTOTRANSFUSION/PLEURAL DRAINAGE VENOUS | 1989-03-10 | 37 |
| K875095 | Pall Biomedical Products Co. | PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANE | 1988-02-29 | 81 |
| K874405 | Pall Biomedical Products Co. | PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE | 1987-12-30 | 63 |
| K855067 | Cobe Laboratories, Inc. | SWANK CARDIOTOMY SUCTION LINE BLOOD FILTER CA100 | 1986-02-26 | 70 |
Recalls for JOD devices
openFDA lists no recalls for product code JOD.
Frequently asked questions
What is FDA product code JOD?
JOD is the FDA product code for filter, blood, cardiotomy suction line, cardiopulmonary bypass. It is a Class II device, regulated under 21 CFR 870.4270 and reviewed by the Cardiovascular panel.
What device class is JOD?
Class II, regulation 21 CFR 870.4270. Typical premarket route: 510(k).
How long does a 510(k) take for product code JOD?
Across 12 cleared submissions the average was 74 days from receipt to decision (median 60).
Which companies have the most JOD clearances?
Medical, Inc. (4); Pall Biomedical Products Co. (2); Cobe Laboratories, Inc. (2); Olson Medical Sales, Inc. (1); Gish Biomedical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JOD
- Run a recall and safety report across every JOD manufacturer
- Watch product code JOD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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