Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HND · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
28 daysmedian FDA review time
38 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K863990 | THORNTON TITANIUM SILVER SPATULA | Keeler Instruments, Inc. | 1986-10-31 | 17 | 0 |
| K810937 | ANIS IRRIGATING SPATULA | American V. Mueller | 1981-05-15 | 38 | 0 |
| K801609 | MADDOX LENS SPATULA CAT. #7245 | Edward Weck, Inc. | 1980-08-13 | 29 | 0 |
| K801608 | MCCULLEY CONTINUOUS SUTURE TIGHTNER | Edward Weck, Inc. | 1980-08-12 | 28 | 0 |
| K791983 | SPATULA'S #'S 7618,7248,7240,7242,5108 | Edward Weck, Inc. | 1979-10-04 | 9 | 0 |
| K761253 | CYCLODIALYSIS SPAT. 15MM BLADE TITANIUM | Edward Weck, Inc. | 1976-12-16 | 3 | 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