Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Alphatek Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
87 daysmedian FDA review time
131 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K023613 | AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036 | Alphatek Corp. | 2003-01-23 | 87 | 0 |
| K931882 | MAMMO-300 AUTOMATIC X-RAY FILM PROCESSOR | Alphatek Corp. | 1993-08-23 | 131 | 0 |
| K931883 | AX-390SE AUTOMATIC X-RAY FILM PROCESSOR 9586.033 | Alphatek Corp. | 1993-08-23 | 131 | 0 |
| K925569 | AX-700LE AUTOMATIC X-RAY FILM PROCESSOR | Alphatek Corp. | 1993-01-15 | 73 | 0 |
| K924430 | AX-300SE AUTOMATIC X-RAY FILM PROCESSOR, 6586.027 | Alphatek Corp. | 1992-11-27 | 87 | 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