Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FLI — Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
60 daysmedian FDA review time
104 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K904921 | STERI-VAC(TM) AERATOR MODEL XL | 3M Health Care, Ltd. | 1990-12-05 | 35 | 0 |
| K902906 | GAS-VAK(R) COMBINATION STERILIZER & VENTILATOR | Gas-Vak | 1990-10-15 | 104 | 0 |
| K831595 | CASTLE MODEL 3341 & 3441 & 4141 GAS AER | Castle Co. | 1983-06-15 | 29 | 0 |
| K830165 | BEAR JET 150 VENTILATOR | Bear Medical Systems, Inc. | 1983-04-12 | 84 | 0 |
| K813201 | CASTLE #3241 GAS AERATOR | Sybron Corp. | 1981-12-31 | 48 | 0 |
| K790677 | EO EVACUATING SYSTEM I | Castle Co. | 1979-05-07 | 28 | 0 |
| K781484 | CASTLE MODEL 3146 GAS AERATOR | Castle Co. | 1978-10-27 | 60 | 0 |
| K761341 | PORTAGAS AERATOR | Amsco Co. | 1977-02-28 | 62 | 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