Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HBE — Predicate Candidate Screening
65 FDA 510(k) clearances under this product code; the 50 most recent screened below.
100 daysmedian FDA review time
263 days90th percentile
65clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253627 | Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); | Surgify Medical OY | 2026-03-26 | 127 | 11 |
| K250815 | Hubly Drill (H100) | Hubly, Inc. | 2025-11-06 | 234 | 0 |
| K252060 | GREEN | Phasor Health, LLC | 2025-10-31 | 122 | 0 |
| K252662 | UniBur | Nakanishi, Inc. | 2025-09-19 | 28 | 0 |
| K251433 | Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); | Surgify Medical OY | 2025-06-04 | 27 | 3 |
| K250380 | Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); | Surgify Medical OY | 2025-03-13 | 30 | 5 |
| K250374 | iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); | Stryker Instruments | 2025-03-11 | 29 | 0 |
| K232684 | Surgify Halo | Surgify Medical OY | 2023-11-29 | 89 | 0 |
| K230619 | Hubly Electric Drill (H100) | Hubly, Inc. | 2023-05-04 | 59 | 0 |
| K223199 | 2.1 x 255mm Drill, 22mm Stop | Biomet Microfixation | 2022-11-15 | 33 | 0 |
| K213072 | 2.1 x 255mm Drill, 22mm Stop | Biomet Micofixation | 2022-08-23 | 334 | 0 |
| K213208 | Twist Drills | Biomet Microfixation | 2021-12-23 | 85 | 0 |
| K213454 | Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Sto | Medtronic Powered Surgical Solutions | 2021-11-23 | 28 | 0 |
| K202120 | P300 Attachment | Nakanishi, Inc. | 2021-10-22 | 449 | 0 |
| K203739 | ELAN 4 Electro Motor System | Aesculap, Inc. | 2021-08-24 | 245 | 0 |
| K210377 | Stryker iBur hubs and cutting accessories | Stryker Corporation | 2021-06-30 | 141 | 10 |
| K191479 | Velocity Alpha Highspeed Surgical Drill System | Adeor Medical AG | 2021-04-11 | 677 | 0 |
| K183203 | ELAN 4 Tools | Aesculap, Inc. | 2019-08-09 | 263 | 0 |
| K183545 | Anspach Helix Dissection Tools | The Anspach Effort, Inc. | 2019-07-19 | 211 | 0 |
| K191049 | Stryker MIS and Footed Attachments | Stryker Corporation | 2019-06-18 | 60 | 0 |
| K190172 | Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachmen | Stryker | 2019-06-14 | 133 | 0 |
| K182527 | ELAN 4 Tools | Aesculap, Inc. | 2019-01-19 | 127 | 0 |
| K172709 | ELAN 4 Electro Motor System Tools | Aesculap, Inc. | 2018-10-17 | 404 | 0 |
| K182436 | POWEREASE System | Medtronic Sofamor Danek USA, Inc. | 2018-10-04 | 27 | 0 |
| K170442 | Cranial Drill Bits and Accessories | Ad-Tech Medical Instrument Corporation | 2017-09-07 | 205 | 0 |
| K162542 | OsteoMed PINNACLE Driver | Osteomed | 2017-05-19 | 249 | 0 |
| K161704 | Phasor Drill | Biotex, Inc. | 2016-12-01 | 164 | 1 |
| K153519 | DReal | Carevature Medical, Ltd. | 2016-03-16 | 99 | 0 |
| K143399 | Stryker Footed Attachments and Cutting Accessories | Stryker Corp. | 2015-05-08 | 161 | 1 |
| K143540 | Stryker MIS Attachments and Cutting Accessories | Stryker Corporation | 2015-05-01 | 137 | 0 |
| K143320 | Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachmen | Stryker Corp. | 2015-04-23 | 155 | 6 |
| K130755 | HICUT HIGHSPEED INSTRUMENT | Adeor Medical AG | 2014-06-27 | 465 | 0 |
| K132436 | VARIOGUIDE DRILL KIT | Mri Interventions, Inc. | 2014-03-20 | 227 | 0 |
| K123270 | POWEREASE SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2013-01-11 | 84 | 0 |
| K121264 | TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULE | Medtronic Surgical Technologies | 2012-08-27 | 123 | 0 |
| K113476 | ANSPACH DISSECTION TOOLS | The Anspach Effort, Inc. | 2011-12-16 | 24 | 35 |
| K111520 | IPC POWEREASE SYSTEM | Medtronic Xomed, Inc. | 2011-10-26 | 146 | 2 |
| K081475 | ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS | Medtronic Xomed, Inc. | 2008-10-17 | 143 | 2 |
| K080802 | EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE> | The Anspach Effort, Inc. | 2008-04-30 | 40 | 23 |
| K072315 | MIDAS REX CURVED BUR | Medtronic Powered Surgical Solutions | 2007-09-18 | 29 | 0 |
| K070876 | STRYKER TWIST DRILLS | Stryker Craniomaxillofacial | 2007-04-27 | 29 | 0 |
| K062842 | TWIST DRILL | Walter Lorenz Surgical, Inc. | 2006-12-04 | 73 | 1 |
| K050628 | ANSPACH COUPLER | The Anspach Effort, Inc. | 2005-04-07 | 27 | 0 |
| K042783 | ANSPACH MINIMAL ACCESS SPINAL ATTACHMENT (MASA) SYSTEM | The Anspach Effort, Inc. | 2004-12-17 | 72 | 24 |
| K040076 | ANSPACH ADVANCED MICRO SAW ATTACHMENTS | The Anspach Effort, Inc. | 2004-03-15 | 61 | 3 |
| K032303 | STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM | Stryker Instruments | 2004-01-16 | 175 | 65 |
| K030172 | SMALL HIGH SPEED MOTOR DRILL SYSTEM | Brasseler USA I, L.P. | 2003-04-03 | 76 | 0 |
| K022942 | CRANIOCUT | Aesculap, Inc. | 2002-10-21 | 46 | 0 |
| K014060 | MICROAIRE 1000E SYSTEM | Microaire Surgical Instruments, Inc. | 2002-03-05 | 85 | 0 |
| K002903 | ANSPACH ANGLED MICRONOSE ATTACHMENT | The Anspach Effort, Inc. | 2000-10-24 | 36 | 1 |
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