Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GFA · Predicate Candidate Screening
27 FDA 510(k) clearances under this product code; the 50 most recent screened below.
41 daysmedian FDA review time
233 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K971978 | GRAFT HARVESTING SAWBLADES | Wrightmedicaltechnologyinc | 1997-06-18 | 20 | 0 |
| K954483 | STRYKER SAGITTAL SAW ATTACHMENT | Stryker Instruments | 1996-01-30 | 125 | 0 |
| K955229 | WRIGHT MEDICAL TECHNOLOGY SAWBLADES | Wrightmedicaltechnologyinc | 1996-01-18 | 65 | 0 |
| K953012 | DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS | Boston Surgical Products, Inc. | 1995-07-12 | 14 | 0 |
| K950403 | SURGICAL SAW BLADES | Transidyne General Corp. | 1995-02-21 | 21 | 0 |
| K940501 | RE-SHARPENABLE SAW BLADES | Adven Medical | 1994-06-28 | 146 | 0 |
| K933595 | BUR, SURGICAL, GENERAL & PLASTIC SURGERY | Omega Surgical Instruments, Inc. | 1994-03-16 | 233 | 0 |
| K935391 | SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES | 3M Health Care, Sarns | 1994-02-24 | 108 | 2 |
| K934603 | SURGICAL SAW BLADES | American Medical Specialties, Inc. | 1994-02-22 | 151 | 0 |
| K931769 | SNAP OSCILLATING SAW | Surgiquip, Inc. | 1994-01-27 | 293 | 0 |
| K934390 | OSCILLATING BONE SAW BLADE, 6200 SERIES | Boehringer Laboratories | 1994-01-26 | 139 | 0 |
| K931210 | INTERMEDICS ORTHOPEDICS SAW BLADE | Intermedics Orthopedics | 1993-11-18 | 253 | 0 |
| K933298 | SAW BLADE | Omega Surgical Instruments, Inc. | 1993-08-09 | 33 | 0 |
| K924953 | FLUID COOLED BONE SAW BLADE, 6000 SERIES | Boehringer Laboratories | 1993-01-21 | 113 | 0 |
| K912761 | SURGICAL SAW BLADES | Blairden Precision Instruments, Inc. | 1991-07-19 | 25 | 0 |
| K896280 | MICRO-AIRE OSCILLATING SAW BLADE 202C-25, 202C-50 | Micro-Aire Surgical Instruments, Inc. | 1989-11-22 | 22 | 0 |
| K863788 | SAWBLADE | Tava Surgical Instruments | 1986-10-14 | 18 | 0 |
| K861876 | CRANIO BLADES AND WIRE PASS DRILL | New England Surgical Instrument Corp. | 1986-05-30 | 15 | 0 |
| K854192 | ANADIAS NASAL SAW BLADES | Anadias, Inc. | 1985-11-13 | 29 | 0 |
| K851880 | BRIMFIELD SCIEN. INSTRU. DISPOS. STERILE SURG. BLA | J-Pac, LLC | 1985-05-21 | 22 | 0 |
| K831714 | MICRO-AIRE REPLACEMENT SURG. SAW BLADE | Micro-Aire Surgical Instruments, Inc. | 1983-07-07 | 41 | 0 |
| K830434 | DISPOSABLE INTRA-ARTICULAR BLADE | Concept, Inc. | 1983-04-12 | 62 | 0 |
| K821487 | MICRO-SURGICAL POWER INSTRUMENT SYS. | Spire Medical, Inc. | 1982-07-02 | 45 | 0 |
| K820601 | REPLACEMENT SAW BLADES FOR STRYKER AIR | Micro-Aire Surgical Instruments, Inc. | 1982-03-23 | 18 | 0 |
| K811506 | MICRO-AIRE REPLACEMENT SAW BLADES | Micro-Aire Surgical Instruments, Inc. | 1981-08-13 | 78 | 0 |
| K810045 | I.M. RETROGRADE BLADES | Hogan & Hartson | 1981-02-12 | 35 | 0 |
| K802838 | STERNUM SAW BLADE | Amsco Co. | 1980-12-11 | 29 | 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