Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cher Mel Corp. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
80 daysmedian FDA review time
367 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K863040 | DISPOSABLE INTRAVENOUS HYPERALIMENTATION BAGS | Cher Mel Corp. | 1986-10-31 | 80 | 0 |
| K851516 | CHERMEL SCALP VEIN SET | Cher Mel Corp. | 1985-08-23 | 130 | 0 |
| K842203 | LITTMAN TYPE SH-6010, NURSE TYPE | Cher Mel Corp. | 1985-06-06 | 367 | 0 |
| K843324 | SPRAGUE RAPPAPORT/SH-6008 DISPOS. STETH | Cher Mel Corp. | 1985-06-06 | 286 | 0 |
| K842823 | CHERMEL OSTEOTOMES | Cher Mel Corp. | 1984-08-02 | 14 | 0 |
| K842824 | CHERMEL BONE CHISELS | Cher Mel Corp. | 1984-08-02 | 14 | 0 |
| K842822 | CHERMEL BONE GOUGES | Cher Mel Corp. | 1984-08-02 | 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