Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
ERL · Predicate Candidate Screening
91 FDA 510(k) clearances under this product code; the 50 most recent screened below.
77 daysmedian FDA review time
243 days90th percentile
91clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243280 | Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M- | W&H Dentalwerk Buermoos GmbH | 2025-07-03 | 259 | 0 |
| K233958 | hekaDrill | Zethon, Ltd. | 2024-03-14 | 90 | 0 |
| K221184 | ORiGO System | Bien-Air Surgery SA | 2022-11-02 | 191 | 0 |
| K213221 | AMADEO, M-UK1015 (incl. attachments and accessories) | W&H Dentalwerk Buermoss GmbH | 2022-05-26 | 239 | 0 |
| K212650 | Celeris, Disposable Sinus Debrider | Gyrus Acmi, Inc. | 2022-01-19 | 149 | 0 |
| K211490 | Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plu | Stryker Corporation | 2021-06-09 | 27 | 0 |
| K200318 | UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillC | KARL STORZ Endoscopy-America, Inc. | 2020-10-22 | 258 | 0 |
| K190715 | EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Tr | Interscope, Inc. | 2019-12-13 | 269 | 0 |
| K180063 | OCM-G1 Attachment | The Anspach Effort, Inc. | 2018-03-27 | 77 | 0 |
| K171840 | Stryker Consolidated Operating Room Equipment (CORE) 2 Conso | Stryker Corporation | 2017-09-15 | 87 | 0 |
| K163247 | 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider | Laurimed, LLC | 2017-03-09 | 111 | 0 |
| K161376 | DragonFly Surgical Drill System | Grace Medical, Inc. | 2016-08-25 | 99 | 0 |
| K161101 | PolypVac Microdebrider (3.3mm and 4.0mm) | Laurimed, LLC | 2016-06-22 | 64 | 0 |
| K152744 | DIEGO ELITE DRILL | Gyrus Acmi, Inc. | 2016-06-10 | 261 | 0 |
| K150969 | Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut- | Karl Storz Endoscopy America, Inc. | 2016-01-08 | 270 | 0 |
| K152641 | Pi Drive Plus Motor, Extender | Stryker Corporation | 2015-11-20 | 66 | 0 |
| K150728 | XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole | Medtronic Xomed, Inc. | 2015-08-14 | 147 | 0 |
| K143492 | OSSEOSTAP Microdrill System (control unit and handpiece), OS | Bien-Air Surgery SA | 2015-03-04 | 86 | 0 |
| K141935 | STRYKER S2 DRILL | Stryker Corporation | 2014-09-26 | 71 | 0 |
| K131053 | ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTA | The Anspach Effort, Inc. | 2013-12-31 | 259 | 0 |
| K133133 | LAURIMED POLYPVAC MICRODEBRIDER | Laurimed, LLC | 2013-12-23 | 84 | 1 |
| K121678 | DTAD | Gyrus Acmi, Inc. | 2012-08-30 | 84 | 0 |
| K112593 | STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM | Stryker Corporation | 2012-05-01 | 237 | 0 |
| K083720 | OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K | Bien-Air Surgery SA | 2009-03-20 | 95 | 0 |
| K081814 | REPROCESSED ENT SHAVERS | Sterilmed, Inc. | 2008-12-17 | 174 | 0 |
| K080052 | STRYKER ESSX WITH NAVIGATION MOUNT | Stryker Corp. | 2008-10-02 | 268 | 0 |
| K080722 | PRIMADO SURGICAL DRILL | Nakanishi, Inc. | 2008-09-17 | 188 | 0 |
| K081277 | XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POW | Medtronic Xomed, Inc. | 2008-09-05 | 123 | 0 |
| K073633 | STRYKER ESSX MICRODEBRIDER SYSTEM | Stryker Ireland Ltd., Instruments Division | 2008-08-26 | 244 | 0 |
| K073255 | XPS 3000 SYSTEM | Medtronic Xomed, Inc. | 2008-03-24 | 126 | 0 |
| K053262 | KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES | KARL STORZ Endoscopy-America, Inc. | 2005-12-19 | 27 | 0 |
| K041523 | XPS 3000 SYSTEM | Medtronic Xomed, Inc. | 2004-07-23 | 45 | 0 |
| K041413 | XPS 3000 SYSTEM | Medtronic Xomed, Inc. | 2004-07-12 | 46 | 0 |
| K040300 | STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) | Stryker Instruments | 2004-03-03 | 23 | 8 |
| K034004 | DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE | Gyrus Ent LLC | 2004-03-03 | 70 | 0 |
| K023070 | SODEM HIGH SPEED SYSTEM (PNEUMATIC) | Sodemsystems | 2003-01-28 | 134 | 0 |
| K021098 | DAUM-LECTRIC MRI DRILLING MACHINE | Mri Devices Daum GmbH | 2002-12-03 | 243 | 0 |
| K021811 | UNIDRIVE II PLUS DISPOSABLE TUBING SET | Mtp Medical Technical Promotion GmbH | 2002-06-19 | 16 | 0 |
| K020594 | DIEGO POWERED DISSECTOR AND DRILL SYSTEM | Gyrus Ent LLC | 2002-03-08 | 14 | 0 |
| K012456 | SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT) | Sodemsystems | 2001-09-21 | 51 | 0 |
| K011321 | MODIFICATION TO XPS 3000 SYSTEM | Medtronic Xomed, Inc. | 2001-06-26 | 60 | 0 |
| K011381 | HUMMER IV MICRODEBRIDER SYSTEM | Stryker Instruments | 2001-05-25 | 18 | 1 |
| K003994 | KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES | KARL STORZ Endoscopy-America, Inc. | 2001-04-13 | 108 | 0 |
| K002224 | XPS 3000 SYSTEM | Medtronic Xomed | 2000-12-04 | 133 | 0 |
| K002828 | XPS NITRO SYSTEM | Xomed, Inc. | 2000-10-17 | 36 | 1 |
| K992994 | TURBO 7000 SHAVER AND DRILL CONSOLE; TURBO 7000 HANDPIECES; | Gyrus Ent LLC | 1999-11-23 | 77 | 0 |
| K990038 | HUMMER TRAK SYSTEM | Stryker Endoscopy | 1999-02-19 | 44 | 0 |
| K983050 | PNEUMATIC CUTTER SYSTEM | Surgical Laser Technologies, Inc. | 1998-11-25 | 85 | 0 |
| K983224 | XPS DRILL SYSTEM | Xomed, Inc. | 1998-10-21 | 37 | 0 |
| K981041 | SLT BIPOLAR SHEATH | Surgical Laser Technologies, Inc. | 1998-08-27 | 160 | 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