Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FWW · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
139 daysmedian FDA review time
241 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K953961 | OSTEONICS INSIGHT KNEE POSITIONING & ALIGNMENT SYSTEM | Osteonics Corp. | 1995-11-29 | 99 | 0 |
| K935356 | CAPTAIN'S CHAIR ACCESSORY TO AMSCO SURGICAL TABLES | Amsco American Sterilizer Co. | 1994-03-23 | 139 | 0 |
| K931876 | FISK ARM SUPPORT | Vvortex International Corp. | 1993-09-09 | 148 | 0 |
| K924713 | UNIVERSAL SURGICAL INSTRUMENT HOLDER | T. Korossurgical Instruments Corp. | 1993-05-17 | 241 | 0 |
| K863161 | TABLE, OPERATING ROOM, HYDRAULIC | Kamiya Tsusan Kaisha, Ltd. | 1986-09-05 | 18 | 0 |
| K853479 | SKYTRON ELITE 300 SURGERY TABLE | Skytron, Div. the Kmw Group, Inc. | 1985-09-05 | 16 | 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