Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical, Inc. — Predicate Candidate Screening
21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
22 daysmedian FDA review time
85 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K926454 | ANESTHESIA RESPIRATORY BREATH CIRCUIT PACKS/COMPON | Medical, Inc. | 1993-06-22 | 180 | 0 |
| K894839 | OS-1 OCCLUSION SYSTEM - 1 | Medical, Inc. | 1989-10-24 | 85 | 0 |
| K872001 | MODEL TPC-1A OXYGEN ANALYZER | Medical, Inc. | 1987-06-15 | 20 | 0 |
| K863806 | MODEL A-1 OXYGEN ANALYZER | Medical, Inc. | 1986-10-15 | 15 | 0 |
| K862609 | INTERFACE ARTERIAL BLOOD FILTER, MODEL 44 | Medical, Inc. | 1986-09-04 | 58 | 0 |
| K862591 | INTERFACE ARTERIAL BLOOD FILTER, MODEL 42 | Medical, Inc. | 1986-09-04 | 59 | 0 |
| K861226 | INTERFACE CRYSTALLOID CARDIOPLEGIC FILTER MODEL 70 | Medical, Inc. | 1986-06-02 | 62 | 0 |
| K851370 | INTERFACE TRANSFUSION BLOOD FILTER #35 | Medical, Inc. | 1985-06-27 | 83 | 0 |
| K823261 | INTERFACE TRANSFUSION BLOOD FILTER #30 | Medical, Inc. | 1983-01-07 | 66 | 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 |
| K823258 | INTERFACE ARTERIAL BLOOD FILTER #40 | Medical, Inc. | 1982-11-24 | 22 | 0 |
| K813131 | INTERFACE ARTERIAL BLOOD FILTER | Medical, Inc. | 1981-11-27 | 22 | 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 |
| K812243 | INTERFACE CARDIOTOMY BLOOD FILTER #51 | Medical, Inc. | 1981-08-25 | 14 | 0 |
| K801451 | ISONEPHROS-PEDIATRIC, STANDARD, OPTIMUM | Medical, Inc. | 1980-09-26 | 95 | 0 |
| K790758 | HEMOCLEAR U-NEPHROS 1.0 DIALYZER | Medical, Inc. | 1979-05-08 | 21 | 0 |
| K781795 | DIALYZER, PARALLEL FLOW DISPOSABLE | Medical, Inc. | 1978-12-15 | 51 | 0 |
| K781383 | INTERFACE CARDIOTOMY BLOOD FILTER | Medical, Inc. | 1978-09-27 | 47 | 0 |
| K771862 | TRANSFUSION BLOOD FILTER | Medical, Inc. | 1977-10-13 | 10 | 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