FDA product code KRJ: Filter, Prebypass, Cardiopulmonary Bypass
KRJ is the FDA product code for filter, prebypass, cardiopulmonary bypass. It is a Class II device, regulated under 21 CFR 870.4280 and reviewed by the Cardiovascular panel. FDA has cleared 24 510(k) submissions under KRJ, from 13 different applicants. The average 510(k) review took 67 days (median 56).
Classification
| Field | Value |
|---|---|
| Device name | Filter, Prebypass, Cardiopulmonary Bypass |
| Device class | Class II |
| Regulation | 21 CFR 870.4280 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KRJ clearance
Top KRJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medtronic Blood Systems, Inc. | 4 | 1989-02-22 |
| Pall Biomedical Products Co. | 3 | 1988-02-29 |
| Medical, Inc. | 3 | 1986-06-02 |
| Porous Media Corp. | 2 | 1999-10-01 |
| American Omni Medical, Inc. | 2 | 1990-04-03 |
8 more applicants have KRJ clearances. See the full list in Caduvo.
Most recent KRJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K990276 | Porous Media Corp. | POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER | 1999-10-01 | 246 |
| K982385 | Porous Media Corp. | POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER | 1999-02-01 | 207 |
| K940126 | Avecor Cardiovascular, Inc. | AVECOR PRE-BYPASS FILTER | 1994-06-28 | 169 |
| K900672 | American Omni Medical, Inc. | PREBYPASS FILTER, CAT. NO. FPB-5 | 1990-04-03 | 49 |
| K885154 | Medtronic Blood Systems, Inc. | INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEM | 1989-02-22 | 69 |
Recalls for KRJ devices
openFDA lists no recalls for product code KRJ.
Frequently asked questions
What is FDA product code KRJ?
KRJ is the FDA product code for filter, prebypass, cardiopulmonary bypass. It is a Class II device, regulated under 21 CFR 870.4280 and reviewed by the Cardiovascular panel.
What device class is KRJ?
Class II, regulation 21 CFR 870.4280. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KRJ?
Across 24 cleared submissions the average was 67 days from receipt to decision (median 56).
Which companies have the most KRJ clearances?
Medtronic Blood Systems, Inc. (4); Pall Biomedical Products Co. (3); Medical, Inc. (3); Porous Media Corp. (2); American Omni Medical, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code KRJ
- Run a recall and safety report across every KRJ manufacturer
- Watch product code KRJ 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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