Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GES — Predicate Candidate Screening
48 FDA 510(k) clearances under this product code; the 50 most recent screened below.
29 daysmedian FDA review time
67 days90th percentile
48clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K032242 | PERSONNA PLUS SAFETY SCALPEL SYSTEM | Omi Manufacturing Pty., Ltd. | 2003-09-23 | 64 | 0 |
| K932998 | EASY-ON | Devon Industries, Inc. | 1993-08-18 | 61 | 0 |
| K923170 | LOS ALAMOS RETRACTABLE KNIFE | Innovative Surgical Technology, Inc. | 1993-02-18 | 234 | 1 |
| K915119 | SCALPEL BLADE REMOVER (BLADEGARD) | Intergrated Visual, Inc. | 1992-05-05 | 174 | 0 |
| K911913 | PRECISION GLIDE - ENHANCED SURGICAL BLADE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-05-13 | 13 | 0 |
| K900266 | STERILE CARBON STEEL SURGICAL BLADE | Rahn Laboratories | 1990-03-01 | 42 | 0 |
| K884862 | ANCHOR DOUBLE-EDGE MYRINGOTOMY BLADE | Anchor Products Co. | 1988-12-27 | 36 | 0 |
| K881638 | SURGICAL BLADE | Far East Intl. Trading Corp. | 1988-06-15 | 62 | 0 |
| K880244 | SURGICAL BLADES | Ailee C/O Havel'S, Inc. | 1988-02-10 | 21 | 0 |
| K873493 | NINJA SCALPEL | Primrose Medical, Inc. | 1987-09-24 | 24 | 0 |
| K873142 | PERSONNA DISPOSABLE SCALPEL | American Safety Razor Co. | 1987-09-04 | 25 | 0 |
| K863867 | DEXTRA DISPOSABLE BLADES | Storz Instrument Co. | 1986-10-24 | 21 | 0 |
| K863885 | SABLE BLADES | Sable Industries | 1986-10-24 | 18 | 0 |
| K863211 | KEISEI SURGICAL BLADES (STERILE & NON-STERILE) | Keisei Medical Industrial Co., Ltd. | 1986-09-02 | 13 | 0 |
| K863214 | KEISEI MICRO-BLADES (STERILE AND NON-STERILE) | Keisei Medical Industrial Co., Ltd. | 1986-09-02 | 13 | 0 |
| K855104 | ANGIOMED SKIN FASCIA KNIFE | Angiomed U.S., Inc. | 1986-01-24 | 32 | 0 |
| K854859 | BLADES, SCALPEL STAINLESS STEEL | Medelec Intl. Corp. | 1985-12-24 | 19 | 0 |
| K854860 | BLADES, SCALPEL CARBON STEET | Medelec Intl. Corp. | 1985-12-24 | 19 | 0 |
| K854620 | SURGICAL BLADES | Niraj Industries | 1985-12-17 | 29 | 0 |
| K854561 | BLADE, SCALPEL | Medelec Intl. Corp. | 1985-12-02 | 18 | 0 |
| K853528 | STAINLESS STEEL & CARBON STEEL STERILE BLADES | Abco Dealers, Inc. | 1985-09-24 | 32 | 0 |
| K852661 | APOLLO STERILE BLADES | Orthofab, Inc. | 1985-07-11 | 17 | 0 |
| K852141 | STERILE SURGICAL BLADES | Miltex Instrument Co. | 1985-06-13 | 28 | 0 |
| K851157 | SURGIMED - SURGICAL BLADES | Surgimed Corp. | 1985-04-25 | 34 | 0 |
| K844759 | SURGICAL SCALPEL BLADES & DISPOSABLES | Cross Country Paper Products Corp. | 1985-01-18 | 42 | 0 |
| K844001 | LANCE BLADES & SCALPELS | Perry, Div. | 1984-11-08 | 27 | 0 |
| K841883 | SURGEON'S BLADES STERILE BLADE | An-Med Intl. | 1984-06-05 | 29 | 0 |
| K841320 | PERCUTANEOUS TRIG. FINGER RELEASE KNIFE | Anapach Effort, Inc. | 1984-04-24 | 22 | 0 |
| K834514 | FASCIA CUTTER | Stryker Corp. | 1984-03-12 | 82 | 0 |
| K834194 | JAKOBI SURG. INSTRUMENTS #1 19/10/26 | Imm Enterprises , Ltd. | 1984-01-27 | 67 | 0 |
| K834182 | H.R. JAKOBI SURG. INSTRUMENTS #11 27/37 | Imm Enterprises , Ltd. | 1984-01-27 | 67 | 0 |
| K834195 | JAKOBI SURG. INSTRUMENTS #11 11/13/14 | Imm Enterprises , Ltd. | 1984-01-27 | 67 | 0 |
| K821737 | DISP. MICROSURGICAL KNIVES | Coburn Optical Ind., Inc. | 1982-07-02 | 18 | 0 |
| K812516 | SURGICAL BLADES & SCAPELS (SMPL. W/510K) | Needle Industries(Usa), Inc. | 1981-10-02 | 30 | 0 |
| K812526 | MICRO BLADE II | Vxtra Corp. | 1981-09-16 | 14 | 0 |
| K812160 | MICROSURGICAL BLADE | Vxtra Corp. | 1981-08-31 | 33 | 0 |
| K812071 | RK IV SURGICAL BLADES | Santa Barbara Medco, Inc. | 1981-08-31 | 41 | 0 |
| K810572 | BLADE, HANDLE, SCALPEL FORCEPS, SURGERY | Technical Resources, Inc. | 1981-03-20 | 17 | 0 |
| K781716 | BLADE, 20 ANGLE/MICRO BLADE HOLDER | Edward Weck, Inc. | 1978-10-24 | 19 | 0 |
| K771045 | BLADES, SCALPEL | American Safety Razor Co. | 1977-06-22 | 12 | 0 |
| K770800 | HANDLES, BLADE, SURGICAL | Lukens Corp. | 1977-05-06 | 4 | 0 |
| K770798 | BLADES, SURGICAL, STERILE | Lukens Corp. | 1977-05-06 | 4 | 0 |
| K770217 | LANCE LTD. STERI. STITCH CUTTER BLADE | Aeroceuticals | 1977-03-30 | 56 | 0 |
| K761322 | SURGICAL BLADES | Richard-Allan Medical Ind., Inc. | 1977-01-06 | 10 | 0 |
| K760605 | LIGHTCAST II CARBIDE BLADE | Merck, Sharp & Dohme | 1976-10-05 | 27 | 0 |
| K760361 | BLADE, SURGICAL SCALPEL, STERILE | Aeroceuticals | 1976-09-13 | 42 | 0 |
| K760363 | SCALPEL, SURGICAL, STERILE STAINLESS | Aeroceuticals | 1976-09-13 | 42 | 0 |
| K760364 | HANDLE, SCALPEL, STAINLESS STEEL | Aeroceuticals | 1976-09-13 | 42 | 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