Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KRJ — Predicate Candidate Screening
24 FDA 510(k) clearances under this product code; the 50 most recent screened below.
57 daysmedian FDA review time
169 days90th percentile
24clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K990276 | POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER | Porous Media Corp. | 1999-10-01 | 246 | 0 |
| K982385 | POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER | Porous Media Corp. | 1999-02-01 | 207 | 0 |
| K940126 | AVECOR PRE-BYPASS FILTER | Avecor Cardiovascular, Inc. | 1994-06-28 | 169 | 0 |
| K900672 | PREBYPASS FILTER, CAT. NO. FPB-5 | American Omni Medical, Inc. | 1990-04-03 | 49 | 0 |
| K885154 | INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEM | Medtronic Blood Systems, Inc. | 1989-02-22 | 69 | 0 |
| K884390 | INTERSEPT* CRYSTALLOID CARDIOPLEGIA FILTER | Medtronic Blood Systems, Inc. | 1988-12-21 | 64 | 0 |
| K884244 | INTERSEPT* PREBYPASS FILTER | Medtronic Blood Systems, Inc. | 1988-12-05 | 55 | 0 |
| K883086 | INTERSEPT*PREBYPASS FILTER | Medtronic Blood Systems, Inc. | 1988-09-16 | 57 | 0 |
| K875094 | ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE | Pall Biomedical Products Co. | 1988-02-29 | 81 | 0 |
| K871350 | PREBYPASS FILTER | American Omni Medical, Inc. | 1987-06-08 | 63 | 0 |
| K861226 | INTERFACE CRYSTALLOID CARDIOPLEGIC FILTER MODEL 70 | Medical, Inc. | 1986-06-02 | 62 | 0 |
| K850139 | COBE COP FILTER CARDIOPULMONARY PREBYPASS FILTER | Rapid Diagnostic Laboratories, Inc. | 1985-04-10 | 86 | 0 |
| K842141 | SOLUTION CLARIFICATION UNIT | Pall Biomedical Products Co. | 1984-08-03 | 65 | 0 |
| K840450 | SHILEY PREBYPASS FILTER | Shiley, Inc. | 1984-04-17 | 76 | 0 |
| K832594 | PRE-BYPASS FILTER #EC-PBF SERIES | Gish Biomedical, Inc. | 1983-09-20 | 49 | 0 |
| K831286 | ULTIPORE PREBYPASS PLUS FILTER | Pall Biomedical Products Co. | 1983-06-08 | 49 | 0 |
| K812539 | PRE-BYPASS FILTER | Gelman Sciences, Inc. | 1981-10-13 | 40 | 0 |
| K812244 | INTERFACE PRE BYPASS PRIME FILTER #90 | Medical, Inc. | 1981-08-25 | 14 | 0 |
| K812240 | INTERFACE PRE BYPASS PRIME FILTER | Medical, Inc. | 1981-08-25 | 14 | 0 |
| K810395 | PRE-BYPASS FILTER | Texas Medical Products, Inc. | 1981-03-05 | 15 | 0 |
| K803101 | PREBYPASS FILTER CAT.#K-5 | Delta Medical Industries | 1980-12-22 | 13 | 0 |
| K800135 | CARDIOPLEGIA ADMINISTRATION SYSTEM CAS | Bentley Laboratories, Inc. | 1980-02-01 | 11 | 0 |
| K790361 | RECIRCULATION FILTER MODEL RF-10 | Bentley Laboratories, Inc. | 1979-03-28 | 34 | 0 |
| K780485 | PREBYPASS FILTER | Delta Medical Industries | 1978-04-05 | 9 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda