Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Alpha Unlimited, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
28 daysmedian FDA review time
72 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K894646 | #556 DISPOSABLE UMBILICAL CORD CLAMP (2) | Alpha Unlimited, Inc. | 1989-09-05 | 43 | 0 |
| K893428 | ALPHA SHOPPER | Alpha Unlimited, Inc. | 1989-06-12 | 41 | 0 |
| K893429 | ALPHA CONDOR | Alpha Unlimited, Inc. | 1989-06-12 | 41 | 0 |
| K893248 | ALPHA MALLARD | Alpha Unlimited, Inc. | 1989-05-26 | 28 | 0 |
| K853766 | ALPHA SUPER KART | Alpha Unlimited, Inc. | 1985-11-20 | 72 | 0 |
| K841921 | ALPHA PLUS 1 | Alpha Unlimited, Inc. | 1984-05-23 | 13 | 0 |
| K841912 | ALPHA 4 X 4 | Alpha Unlimited, Inc. | 1984-05-23 | 14 | 0 |
| K841920 | MAC-MULTI-ADJUSTABLE CHAIR | Alpha Unlimited, Inc. | 1984-05-23 | 13 | 0 |
| K841919 | ALPHA TRI-KART | Alpha Unlimited, Inc. | 1984-05-23 | 13 | 0 |
| K841911 | ALPHA PUSH KART | Alpha Unlimited, Inc. | 1984-05-23 | 14 | 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