Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HBB — Predicate Candidate Screening
27 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
300 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253772 | Velocity Alpha MR High Speed Surgical Drill System | Adeor Medical AG | 2026-03-06 | 100 | 0 |
| K172907 | ELAN 4 Air Motor System | Aesculap, Inc. | 2018-11-09 | 410 | 2 |
| K163182 | Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic | Medtronic Powered Surgical Solutions | 2017-03-23 | 129 | 0 |
| K150801 | Stryker Maestro Air Motors | Stryker Corporation | 2015-05-22 | 57 | 1 |
| K101168 | LEGEND POWER ADAPTER MODEL: 6475000 | Medtronic Sofamor Danek | 2010-08-24 | 120 | 0 |
| K093361 | SYNTHES AIR PEN DRIVE (APD) SYSTEM | Synthes (Usa) | 2010-04-14 | 168 | 0 |
| K090112 | MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM7 | Medtronic Powered Surgical Solutions | 2009-03-26 | 69 | 0 |
| K061297 | ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM | The Anspach Effort, Inc. | 2007-01-26 | 262 | 3 |
| K061725 | STRYKER ARIA PNEUMATIC SYSTEM | Stryker Instruments | 2006-10-26 | 129 | 0 |
| K042974 | MEDICON VIPAIR HIGH SPEED SYSTEM | Medicon EG | 2005-01-13 | 77 | 0 |
| K041754 | STRYKER MAESTRO SYSTEM | Stryker Corp. | 2004-09-07 | 70 | 0 |
| K040186 | ANSPACH MRI SAFE SURGICAL DRILL SYSTEM | The Anspach Effort, Inc. | 2004-04-15 | 79 | 2 |
| K023066 | DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED | Sodemsystems | 2002-11-25 | 70 | 0 |
| K020069 | MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC | Medtronic Midas Rex | 2002-03-18 | 68 | 8 |
| K013091 | ZMM 2000 ZEPPELIN MILLENNIUM MOTORDRILL SYSTEM | Von Zeppelin GmbH | 2002-01-25 | 130 | 0 |
| K000195 | CRANIAL DRILL | Image-Guided Neurologics, Inc. | 2000-04-20 | 90 | 0 |
| K993851 | SODEM PERFORATOR DRIVE | Sodemsystems | 1999-12-27 | 45 | 0 |
| K994175 | MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL US | Sodemsystems | 1999-12-21 | 11 | 0 |
| K991625 | KOMET XK-95 PERFORATOR MOTOR (MI-102) | Komet Medical | 1999-07-30 | 80 | 0 |
| K983092 | TRITON HUDSON CHUCK ATTACHMENT | Mednext, Inc. | 1998-11-06 | 64 | 0 |
| K980686 | AESCULAP HILAN MOTOR SYSTEM | Aesculap, Inc. | 1998-09-02 | 191 | 0 |
| K972289 | MIDAS REX MOTOR | Midas Rex Pneumatic Tools, Inc. | 1997-09-12 | 85 | 0 |
| K954717 | SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY | Sodem Diffusion SA | 1997-01-22 | 467 | 0 |
| K960630 | ANSPAHC SPEED REDUCER | The Anspach Effort, Inc. | 1996-11-19 | 284 | 2 |
| K962483 | MIDAS REX III MOTOR | Midas Rex Pneumatic Tools, Inc. | 1996-11-19 | 146 | 0 |
| K953434 | MIDAS REX MOTORS, (MIDAS I, MIDAS II & CONVERTIBLE MODELS) | Midas Rex Pneumatic Tools, Inc. | 1996-05-16 | 300 | 0 |
| K895739 | MICROMEDICS SURGICAL DRILL SYSTEM | Micromedics, Inc. | 1989-10-13 | 17 | 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