Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HBC · Predicate Candidate Screening
26 FDA 510(k) clearances under this product code; the 50 most recent screened below.
91 daysmedian FDA review time
359 days90th percentile
26clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233153 | Traus SSG10 Surgical System | Saeshin Precision Co., Ltd. | 2024-09-20 | 359 | 0 |
| K232938 | Traus SSG30 Surgical System | Saeshin Precision Co., Ltd. | 2024-09-16 | 362 | 0 |
| K213697 | ORiGO System | Bien-Air Surgery SA | 2022-10-31 | 342 | 0 |
| K220485 | Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wire | The Anspach Effort, Inc. | 2022-05-19 | 91 | 0 |
| K193630 | hekaDrill | Zethon, Ltd. | 2021-04-09 | 470 | 0 |
| K183515 | MR8 Drill System, Midas Rex MR8 ClearView Tools | Medtronic Powered Surgical Solutions | 2019-05-12 | 145 | 0 |
| K173066 | OSSEODUO Shaver and Drill System | Bien-Air Surgery SA | 2018-06-22 | 266 | 0 |
| K170312 | IPC systems, Legend EHS handpieces and Legend Stylus Touch h | Medtronic Powered Surgical Solutions | 2017-05-15 | 103 | 0 |
| K163565 | MR8 Drill System | Medtronic Powered Surgical Solutions | 2017-03-28 | 99 | 0 |
| K152960 | ELAN 4 Motor System | Aesculap, Inc. | 2016-07-22 | 289 | 0 |
| K133604 | ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS | The Anspach Effort, Inc. | 2014-01-10 | 46 | 10 |
| K132264 | PRIMADO2 TOTAL SURGICAL SYSTEM | Nakanishi, Inc. | 2013-12-17 | 148 | 0 |
| K130497 | D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION | Linvatec Corporation D/B/A Conmed Linvatec | 2013-03-29 | 31 | 0 |
| K083112 | PRIMADO | Nakanishi, Inc. | 2009-04-29 | 190 | 0 |
| K080444 | CONMED LINVATEC OSPREY DRILL SYSTEM | Conmed Linvatec | 2008-04-02 | 43 | 0 |
| K060260 | MICROPOWER HAND PIECE HIGH SPEED DRILL | Linvatec Corp. | 2006-04-10 | 68 | 0 |
| K053526 | MICROSPEED UNI MOTOR SYSTEM | Aesculap, Inc. | 2006-01-18 | 30 | 1 |
| K022986 | THE BIOPLATE BATTERY POWERED DRILL | Bioplate, Inc. | 2002-11-19 | 71 | 0 |
| K012457 | SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY) | Sodemsystems | 2001-10-22 | 82 | 0 |
| K012453 | SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PL | Sodemsystems | 2001-10-22 | 82 | 0 |
| K011444 | ANSPACH EMAX DRILL SYSTEM | The Anspach Effort, Inc. | 2001-08-08 | 89 | 37 |
| K003612 | MICROSPEED EC MOTORSYSTEM GD650/GD653 | Aesculap, Inc. | 2001-02-20 | 90 | 0 |
| K002523 | ADVANTAGE DRIVE SYSTEM | Linvatec Corp. | 2000-10-06 | 52 | 0 |
| K972857 | SERVOTRONIC EC100 SYSTEM | Medicon EG | 1998-01-16 | 168 | 0 |
| K862989 | SURGICAL DRILL (ELECTRIC) INCLUDING HANDPIECE | Entronics | 1986-08-21 | 13 | 0 |
| K812436 | 450/800 DRILL | Black & Decker(Tm) | 1981-11-02 | 68 | 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