Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Chase Mfg. Co. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
66 daysmedian FDA review time
101 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K791513 | ADAMCO DUST COVER | Chase Mfg. Co. | 1979-10-11 | 76 | 0 |
| K790993 | INSTANT HOT & COLD PACKS | Chase Mfg. Co. | 1979-09-07 | 101 | 0 |
| K790644 | SUBMAX | Chase Mfg. Co. | 1979-04-26 | 27 | 0 |
| K780033 | MATTRESSES, CONDUCTIVE & COVERS | Chase Mfg. Co. | 1978-02-21 | 43 | 0 |
| K771792 | ENEMA SET | Chase Mfg. Co. | 1977-10-20 | 28 | 0 |
| K771791 | NEEDLE COUNTING | Chase Mfg. Co. | 1977-10-04 | 12 | 0 |
| K770898 | FRACTURE CAST BRACE KIT, PLASTIC | Chase Mfg. Co. | 1977-07-21 | 66 | 0 |
| K770900 | CAST BRWM, FRACTURE | Chase Mfg. Co. | 1977-07-21 | 66 | 0 |
| K770899 | FRACTURE CAST BRACE, POLY | Chase Mfg. Co. | 1977-07-21 | 66 | 0 |
| K770173 | STOCKINETTE | Chase Mfg. Co. | 1977-02-08 | 13 | 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