Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Alpha Therapeutic Corp. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
97 daysmedian FDA review time
173 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K970225 | ALPHA MICRON 20/40 MICROAGGREGATE FILTER | Alpha Therapeutic Corp. | 1997-02-14 | 28 | 0 |
| K955515 | ALPHA MICRON 20 MICROAGGREGATE FILTER | Alpha Therapeutic Corp. | 1996-02-12 | 70 | 0 |
| K854920 | THERAPY CASSETTS | Alpha Therapeutic Corp. | 1986-05-19 | 160 | 0 |
| K854441 | STUART GILMAN'S WEIGHT LOSS PLAN | Alpha Therapeutic Corp. | 1986-02-10 | 97 | 0 |
| K833294 | ALPHA Y-RECIPIENT SET | Alpha Therapeutic Corp. | 1983-12-27 | 95 | 0 |
| K820447 | ALPHA PLASMA TRANSFER SET | Alpha Therapeutic Corp. | 1982-04-14 | 55 | 0 |
| K810897 | ALPHA PLASTIC PLASMA BOTTLE | Alpha Therapeutic Corp. | 1981-09-23 | 173 | 0 |
| K810761 | ALPHA MICRON-40 FILTER | Alpha Therapeutic Corp. | 1981-06-30 | 102 | 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