Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
GFF · Predicate Candidate Screening
16 FDA 510(k) clearances under this product code; the 50 most recent screened below.
21 daysmedian FDA review time
125 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K974025 | ANSPACH SHIELDED ATTACHMENT | The Anspach Effort, Inc. | 1998-07-06 | 256 | 5 |
| K950449 | SURGICAL BUR | Transidyne General Corp. | 1995-03-01 | 26 | 0 |
| K943758 | SURGICAL BUR | Komet Medical | 1994-08-22 | 20 | 0 |
| K934583 | BURRS | American Medical Specialties, Inc. | 1994-01-26 | 125 | 0 |
| K894438 | MICRO-AIRE CUTTERS FOR MIDAS-REX INSTRUMENTS | Micro-Aire Surgical Instruments, Inc. | 1989-08-21 | 35 | 0 |
| K890090 | DANEK IRRIGATING BURR (DIB) SET | Danek Medical, Inc. | 1989-01-24 | 14 | 0 |
| K883255 | KOMET SURGICAL BUR | Komet Medical, Div. of Brasseler USA I, L.P. | 1988-09-15 | 44 | 0 |
| K880859 | SURGICAL BURS | New England Surgical Instrument Corp. | 1988-03-21 | 20 | 0 |
| K880706 | SURGICAL BURS | Nuell Air Equipment & Hospital Supplies, Inc. | 1988-02-26 | 4 | 0 |
| K872475 | SURGICAL BUR | Tava Surgical Instruments | 1987-07-02 | 9 | 0 |
| K862852 | MICRO-AIRE REPLACE OTOLOGY BURS/ZIM HALL SUR INSTR | Micro-Aire Surgical Instruments, Inc. | 1986-08-11 | 13 | 0 |
| K853658 | BURS FOR MICRO SURGICAL DRILL SYSTEM | Acumed Instruments Corp. | 1985-09-24 | 21 | 0 |
| K850497 | MICRO-AIRE GENERIC BURS & DRILLS | Micro-Aire Surgical Instruments, Inc. | 1985-03-01 | 21 | 0 |
| K841298 | HOLE CHAMFERING DEVICE | Techmedica, Inc. | 1984-04-25 | 26 | 0 |
| K821485 | DERMABRADERS | Spire Medical, Inc. | 1982-06-10 | 23 | 0 |
| K820281 | MICRO-AIRE REPLACEMENT DRILL BURS | Micro-Aire Surgical Instruments, Inc. | 1982-02-23 | 21 | 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