Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KFK — Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K893949 | #157 EXAM LIGHT | Medmark, Inc. | 1989-08-07 | 67 | 0 |
| K894301 | MICRO-AIRE STERNUM SAW 4800 | Micro Surgical Instruments Corp. | 1989-08-03 | 41 | 0 |
| K870157 | OSCILLATING SAW/ RECIPROCATING SAW/ DRILL-REAMER | Micro-Aire Surgical Instruments, Inc. | 1987-02-24 | 42 | 0 |
| K801737 | STERNUM SAW | Amsco Co. | 1980-08-20 | 26 | 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