Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
JOD — Predicate Candidate Screening
12 FDA 510(k) clearances under this product code; the 50 most recent screened below.
63 daysmedian FDA review time
154 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K993060 | GAS FILTER | Olson Medical Sales, Inc. | 2000-03-28 | 197 | 0 |
| K890504 | CARDIOTOMY/AUTOTRANSFUSION/PLEURAL DRAINAGE VENOUS | Gish Biomedical, Inc. | 1989-03-10 | 37 | 0 |
| K875095 | PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANE | Pall Biomedical Products Co. | 1988-02-29 | 81 | 0 |
| K874405 | PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE | Pall Biomedical Products Co. | 1987-12-30 | 63 | 0 |
| K855067 | SWANK CARDIOTOMY SUCTION LINE BLOOD FILTER CA100 | Cobe Laboratories, Inc. | 1986-02-26 | 70 | 0 |
| K841958 | CARDIO METRICS CARDIOTOMY RESERVOIR | Sterile Design, Inc. | 1984-10-15 | 154 | 0 |
| K830634 | CARDIOTOMY FILTER | Texas Medical Products, Inc. | 1983-06-30 | 121 | 0 |
| K823259 | INTERFACE CARDIOTOMY BLOOD FILTER #50 | Medical, Inc. | 1982-11-24 | 22 | 0 |
| K823260 | INTERFACE CARDIOTOMY BLOOD FILTER #51 | Medical, Inc. | 1982-11-24 | 22 | 0 |
| K812243 | INTERFACE CARDIOTOMY BLOOD FILTER #51 | Medical, Inc. | 1981-08-25 | 14 | 0 |
| K781383 | INTERFACE CARDIOTOMY BLOOD FILTER | Medical, Inc. | 1978-09-27 | 47 | 0 |
| K780653 | EXTRACORPEAL CARDIOTOMY BLOOD FILTER | Cobe Laboratories, Inc. | 1978-06-14 | 56 | 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