Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
GFI · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
83 daysmedian FDA review time
267 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K933181 | VALLEYLAB FORCE GSU HANDSET ADAPTER MODEL #E0500 | Valleylab, Inc. | 1993-11-02 | 125 | 0 |
| K932534 | ISI FENESTRATED DISSECTING AND GRASPING FORCEPS | Innovative Surgical, Inc. | 1993-08-19 | 83 | 0 |
| K920001 | HEMOLAB SILIMAT REAGENT | Biomerieux Vitek, Inc. | 1992-09-25 | 267 | 0 |
| K891887 | OSTEOTOMES, VARIOUS TYPES | Zinnanti Surgical Instruments, Inc. | 1989-04-12 | 19 | 0 |
| K852541 | STORZ ION BOND OSTEOTOMES & RASPS, FAST CU BURS | Storz Instrument Co. | 1985-07-11 | 27 | 0 |
| K842823 | CHERMEL OSTEOTOMES | 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