Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KIJ — Predicate Candidate Screening
29 FDA 510(k) clearances under this product code; the 50 most recent screened below.
87 daysmedian FDA review time
425 days90th percentile
29clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K163308 | SMARTO | Jeil Medical Corporation | 2016-12-27 | 34 | 0 |
| K112599 | INSURGICAL SINGLE USE POWER EQUIPMENT | Insurgical, LLC | 2012-11-06 | 426 | 0 |
| K101563 | SMARTO | Jeil Medical Corporation | 2010-12-17 | 196 | 0 |
| K972367 | STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT | Stryker Instruments | 1997-09-04 | 71 | 10 |
| K970378 | STRYKER 2115 REPLACEMENT BATTERY (2115) | Implant Resource, Inc. | 1997-04-30 | 89 | 0 |
| K960711 | ACUMED BONE GRAFT SYSTEM | Acu Med, Inc. | 1996-05-07 | 76 | 2 |
| K951450 | SYSTEM 2000 REPLACEMENT BATTERY, SYSTEM 2000-EXTENDED RUN RE | Strenumed, Inc. | 1995-05-17 | 49 | 0 |
| K944488 | S & S ORTHOPEDIC WIRE DRIVER 701 | S & S Orthopedic , Ltd. | 1995-03-02 | 170 | 0 |
| K941285 | ARTHREX GRAFT HARVESTING KIT | Arthrex, Inc. | 1994-11-14 | 242 | 0 |
| K933101 | THE OSTEOMED B POWER SYSTEM AND ACCESSORIES | Osteomed Corp. | 1994-11-07 | 501 | 0 |
| K933337 | R AND D BATTERY REPLACEMENT | R & D Batteries, Inc. | 1994-04-05 | 271 | 0 |
| K931395 | SERIES 5000 BATTERY POWERED INSTRUMENT SYSTEM | Micro Surgical Instruments Corp. | 1994-01-28 | 315 | 0 |
| K932307 | 3M MAXI-DRIVER II DBATTERY POWERED SYSTEM | 3M Health Care, Ltd. | 1994-01-07 | 241 | 0 |
| K884839 | MODIFIED SAW BLADES TO THE SAGITAL SAW | Dyonics, Inc. | 1988-12-07 | 16 | 0 |
| K873766 | STERNAL POWER AWL | Bowen & Company, Inc. | 1988-11-14 | 425 | 0 |
| K864137 | LYPHOCHEK IMMUNOASSAY SERUM CONTROL LEVEL I,II,III | Bio-Rad | 1986-11-07 | 17 | 0 |
| K850789 | FLUTED SUCTION MENISCAL CUTTER | T. Korossurgical Instruments Corp. | 1985-06-28 | 122 | 0 |
| K844163 | EZ 502 | Aeg Power Tool Corp. | 1985-03-11 | 138 | 0 |
| K844162 | EZ 505 | Aeg Power Tool Corp. | 1985-03-11 | 138 | 0 |
| K822790 | MICRO-CRAFT OSCILLATING SAW HANDPIECE | Xomed, Inc. | 1982-10-22 | 37 | 0 |
| K820367 | INTRA-ARTICULAR SURGICAL SYSTEM | Dyonics, Inc. | 1982-05-07 | 87 | 0 |
| K800314 | POWER PACK | Black & Decker(Tm) | 1980-03-19 | 36 | 0 |
| K800315 | DUAL MPC CHARGER | Black & Decker(Tm) | 1980-03-19 | 36 | 0 |
| K800311 | 450 DRILL/800 DRILL | Black & Decker(Tm) | 1980-02-22 | 10 | 0 |
| K800312 | 150 DRIVER/REAMER | Black & Decker(Tm) | 1980-02-22 | 10 | 0 |
| K800313 | SAGITTAL SAW | Black & Decker(Tm) | 1980-02-22 | 10 | 0 |
| K790063 | DRILL, CORDLESS SURGICAL | Richard'S Medical Equip., Inc. | 1979-02-05 | 21 | 0 |
| K780645 | HMD-2000 BATTERY-POWERED MINI-DRILL, THE | Medishield, Inc. | 1978-05-03 | 16 | 0 |
| K771218 | INTRA-ARTICULAR SHAVER | Dyonics, Inc. | 1978-02-01 | 211 | 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