Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EMF — Predicate Candidate Screening
21 FDA 510(k) clearances under this product code; the 50 most recent screened below.
56 daysmedian FDA review time
111 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K080133 | MOUNTABLE ENDOSCOPIC BLADE | A.M. Surgical, Inc. | 2008-03-13 | 55 | 0 |
| K982142 | MOUNTABLE ENDOSCOPIC KNIFE | A.M. Surgical, Inc. | 1998-12-30 | 196 | 0 |
| K890217 | MICROSURGICAL KNIVES | Kinetic Medical Products | 1989-01-27 | 9 | 0 |
| K890215 | MICROSURGICAL SCARIFIER | Kinetic Medical Products | 1989-01-27 | 9 | 0 |
| K890214 | MICROSURGERY RAZOR BLADE HOLDER | Kinetic Medical Products | 1989-01-27 | 9 | 0 |
| K880094 | VAN-TEC ENDOPYELOTOMY KNIFE | Van-Tec, Inc. | 1988-02-29 | 48 | 0 |
| K863752 | VALTRAC (BAR) REMOVER DEVICE | Davis & Geck, Inc. | 1986-10-24 | 29 | 0 |
| K863549 | REUSABLE/DISPOSABLE AUTOPSY KNIFE SET | Surgipath Medical Industries, Inc. | 1986-09-30 | 18 | 0 |
| K861947 | SURGICAL KNIFE | Sharpoint, Inc. | 1986-06-06 | 17 | 0 |
| K854891 | KNIFE | Euro-Med Intl. | 1986-05-02 | 147 | 0 |
| K851784 | 27-210 PLASTER KNIFE (REINER) | Artiberia | 1985-06-20 | 56 | 0 |
| K843497 | SURGICAL KNIVES & PROBES | Eder Instrument Co, Inc. | 1984-10-31 | 55 | 0 |
| K843371 | VALVOTOMY KNIFE | Downs Surgical , Ltd. | 1984-10-25 | 58 | 0 |
| K834197 | JAKOBI SURG. INSTR- #11 38/39/45/46/67 | Imm Enterprises , Ltd. | 1984-01-27 | 67 | 0 |
| K834184 | H.R. JAKOBI SURG. INSTRUMENTS #11 38/67 | Imm Enterprises , Ltd. | 1984-01-27 | 67 | 0 |
| K832368 | CHANGING METHOD OF STERILITY RELEASE | Devon Industries, Inc. | 1983-10-31 | 105 | 0 |
| K821769 | MICROKNIFE | Biological & Environmental Control Laboratories | 1982-09-14 | 96 | 0 |
| K801585 | HESSBURG-BFRRON TREPHINE | Precision Instruments, Inc. | 1980-10-03 | 84 | 0 |
| K791286 | WECK MICROSURGICAL KNIFE | Vista Medical Products, Inc. | 1979-07-24 | 15 | 0 |
| K780991 | PARALLEL BLADE MARKER | Nestor Engineering Associates, Inc. | 1978-10-03 | 111 | 0 |
| K780989 | DEVIN-NESTOR SQUARE KNIFE | Nestor Engineering Associates, Inc. | 1978-10-03 | 111 | 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