Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
EOB — Predicate Candidate Screening
162 FDA 510(k) clearances under this product code; the 50 most recent screened below.
94 daysmedian FDA review time
282 days90th percentile
162clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261544 | Hydro Irrigation System | Stryker Instruments | 2026-06-17 | 40 | 0 |
| K254133 | ENTity USB Videoscope System | Optim, LLC | 2026-05-14 | 143 | 0 |
| K253184 | Video Rhinolaryngoscope System (Disposable Video Rhinolaryng | Zhuhai Wesee Meditech Co., Ltd. | 2026-03-25 | 180 | 0 |
| K252050 | Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D | Olympus Medical Systems Corporation | 2026-03-20 | 262 | 0 |
| K241731 | Outlook Surgical Versa One System (8900139) | Resnent, LLC | 2025-08-11 | 420 | 0 |
| K243639 | Portare System (FA-001) | Grumpy Innovation, Inc. | 2025-06-05 | 192 | 0 |
| K243380 | VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S | Olympus Medical Systems Corporation | 2025-03-03 | 124 | 0 |
| K234096 | MonoStereo | Medicaltek Co., Ltd. | 2024-09-19 | 268 | 0 |
| K232435 | Rhinolaryngoscope system | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2024-04-26 | 256 | 0 |
| K232015 | ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMO | Atmos Medizintechnik GmbH & Co. KG | 2023-08-03 | 28 | 0 |
| K222587 | PatCom Distal Chip Endoscope | H&A Mui Enterprises, Inc. | 2023-07-28 | 336 | 0 |
| K230536 | Single-use Flexible Rhinolaryngoscope; Digital Video Monitor | Hunan Vathin Medical Instrument Co., Ltd. | 2023-06-14 | 107 | 0 |
| K221660 | RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP | Olympus Medical Systems Corp. | 2022-12-28 | 203 | 1 |
| K221581 | Single-Use Flexible Rhinolaryngoscope | Hunan Vathin Medical Instrument Co., Ltd. | 2022-11-18 | 170 | 0 |
| K220465 | PENTAX Medical EPK-3000 Imaging System with Camera Head PVK- | Pentax of America, Inc. | 2022-11-16 | 272 | 0 |
| K221638 | Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Video | Olympus Medical Systems Corp. | 2022-09-19 | 105 | 0 |
| K214050 | ENT Nasopharyngoscope and Accessories | Medimaging Integrated Solution, Inc (Miis) | 2022-07-01 | 186 | 0 |
| K220004 | Zsquare ENT-Flex Endoscope | Zsquare, Ltd. | 2022-06-14 | 161 | 0 |
| K202727 | Peregrine Endoscopy System | 3nt Medical , Ltd. | 2021-07-23 | 309 | 0 |
| K200609 | ENTity WiFi Video Nasopharyngoscope System | Optim, LLC | 2021-01-13 | 310 | 0 |
| K200740 | HD Video Rhino Laryngoscope | KARL STORZ Endoscopy-America, Inc. | 2020-08-11 | 141 | 0 |
| K192305 | Colibri Endoscopy System | 3nt Medical , Ltd. | 2020-02-27 | 188 | 0 |
| K192090 | CMOS Video Rhino-Laryngoscope SSU | Karl Storz SE & CO. KG | 2020-01-27 | 175 | 0 |
| K191102 | Precision S 4K Sinuscope | Stryker | 2019-09-06 | 134 | 0 |
| K183416 | Rhino-Laryngo Videoscope Olympus ENF-VT3 | Olympus Medical Systems Corp. | 2019-09-06 | 270 | 1 |
| K190972 | Ambu aScope 4 RhinoLaryngo Intervention | Ambu A/S | 2019-07-12 | 88 | 0 |
| K183691 | PENTAX Medical ENT Video Imaging System | Pentax of America, Inc. | 2019-06-12 | 163 | 0 |
| K191080 | Ambu aScope 4 RhinoLaryngo Slim | Ambu A/S | 2019-05-22 | 28 | 0 |
| K182186 | CMOS Video-Rhino-Laryngoscope System | KARL STORZ Endoscopy-America, Inc. | 2019-03-22 | 221 | 0 |
| K182102 | RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, RHINO-LARYNGO VIDE | Olympus Medical Systems Corp. | 2019-02-06 | 187 | 0 |
| K182846 | PENTAX Medical EPK-3000 Video Imaging System | Pentax of America, Inc. | 2019-01-09 | 92 | 0 |
| K181286 | Ambu aScope RLS Slim | Ambu A/S | 2018-11-30 | 198 | 0 |
| K181240 | Rhino-Laryngo Fiberscope Olympus ENF-GP2 | Olympus Medical Systems Corp. | 2018-10-04 | 147 | 0 |
| K171011 | PENTAX Medical VIVIDEO ENT Videoscope Solution | Pentax Medical | 2018-07-18 | 470 | 0 |
| K173855 | Sharpsite AC Rigid Endsocope | Medtronic Xomed, Inc. | 2018-04-20 | 121 | 0 |
| K172156 | PENTAX Medical EPK-3000 Video Imaging System | Pentax Medical | 2018-04-05 | 261 | 0 |
| K171402 | KARL STORZ Slim Nasopharyngolaryngoscope | KARL STORZ Endoscopy-America, Inc. | 2018-02-02 | 266 | 0 |
| K170453 | Medrobotics Flex Robotic System | Medrobotics Corporation | 2017-10-19 | 246 | 0 |
| K161298 | ShenDa Sinuscope | Shenyang Shenda Endoscope Co., Ltd. | 2017-08-25 | 473 | 0 |
| K170285 | AED Sinuscope | National Advanced Endoscopy Devices, Inc. | 2017-08-01 | 183 | 0 |
| K162151 | PENTAX Medical ENT Video Imaging System | Pentax of America, Inc. | 2017-04-20 | 261 | 0 |
| K162410 | TIPCAM 1S 3D System | Karl Storz Endoscopy America, Inc. | 2017-03-02 | 185 | 0 |
| K162916 | 3NT endoscopy system | 3nt Medical , Ltd. | 2017-02-24 | 130 | 0 |
| K153701 | ULYSS Multi View Sinuscope | Sopro-Comeg GmbH | 2016-09-09 | 261 | 0 |
| K153009 | ULTRA Telescopes | Olympus Winter & Ibe GmbH | 2016-04-05 | 174 | 0 |
| K152531 | InstaClear Lens Cleaner | Gyrus Acmi, Inc. | 2016-01-15 | 134 | 2 |
| K150776 | Medrobotics Flex System | Medrobotics Corporation | 2015-07-17 | 115 | 0 |
| K143673 | CMOS Video Nasopharyngoscope System | Schoelly Fiberoptic GmbH | 2015-03-04 | 70 | 0 |
| K142249 | SCHOELLY SINUSCOPE | Schoelly Fiberoptic GmbH | 2015-01-27 | 166 | 0 |
| K131323 | ECLERIS SINUSCOPE | Ecleris USA | 2014-06-09 | 397 | 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