Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Ear, Nose, Throat — Predicate Candidate Screening
3,794 FDA 510(k) clearances under this medical specialty; the 50 most recent screened below.
81 daysmedian FDA review time
251 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261187 | Hearing Aid Feature | Samsung Electronics Co., Ltd. | 2026-07-31 | 112 | 0 |
| K260620 | SeptAlign (SPLN001) | Spirair, Inc. | 2026-07-30 | 155 | 0 |
| K260382 | MONARCH™ Platform (MON-000008) | Auris Health, Inc. | 2026-07-25 | 170 | 0 |
| K261274 | EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for | Cook Ireland, Ltd. | 2026-07-24 | 98 | 0 |
| K254296 | Ossiclear (Ossiclear System) | Sounduct | 2026-07-22 | 203 | 0 |
| K254044 | Hearing assist | Meta Platform Technologies, LLC | 2026-07-13 | 208 | 0 |
| K260902 | Cochlear™ Osia® 3(I) Sound Processor;Cochlear™ Osia® 3 Sound | Cochlear Americas | 2026-07-10 | 114 | 0 |
| K254037 | LungFlow Airway Catheter | Free Flow Medical, Inc. | 2026-07-10 | 206 | 0 |
| K254108 | Jabra Enhance Select Self-fit (Jabra Enhance Select 550) | GN Hearing A/S | 2026-06-25 | 188 | 0 |
| K260992 | iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Pr | Neuralytix | 2026-06-25 | 91 | 0 |
| K261544 | Hydro Irrigation System | Stryker Instruments | 2026-06-17 | 40 | 0 |
| K253137 | FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model E | Fujifilm Corporation | 2026-06-16 | 264 | 0 |
| K260452 | Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, | Zdeer Technology (Henan) Co., Ltd. | 2026-06-15 | 124 | 0 |
| K261256 | Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-A | Shenzhen Magnet Technology Co., Ltd. | 2026-06-11 | 56 | 0 |
| K260614 | Tinnitus Therapy | Sivantos GmbH | 2026-06-10 | 105 | 0 |
| K252624 | KARL STORZ Laryngoscopes and Accessories | KARL STORZ Endoscopy-America, Inc. | 2026-05-15 | 270 | 0 |
| K254133 | ENTity USB Videoscope System | Optim, LLC | 2026-05-14 | 143 | 0 |
| K260565 | SmartClip Delivery Catheter (ADR-1715) | Elucent Medical | 2026-05-14 | 84 | 0 |
| K253580 | Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile | Tedan Surgical Innovations | 2026-04-26 | 160 | 0 |
| K252341 | EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXE | Olympus Medical Systems Corp. | 2026-04-23 | 269 | 0 |
| K252436 | Tula Tympanostomy Tube Delivery Device | Tusker Medical, Inc. | 2026-04-23 | 265 | 0 |
| K251478 | ClearTip TBNA Type | Finemedix Co., Ltd. | 2026-04-16 | 338 | 0 |
| K260420 | LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B | MacroLux Medical Technology Co., Ltd. | 2026-04-08 | 58 | 0 |
| K260718 | mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Pro | MED-EL Elektromedizinische Geräte GmbH | 2026-04-03 | 29 | 0 |
| K260719 | mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosth | MED-EL Elektromedizinische Geräte GmbH | 2026-04-03 | 29 | 0 |
| K260720 | mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stape | MED-EL Elektromedizinische Geräte GmbH | 2026-04-03 | 29 | 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 |
| DEN250014 | Tyto Insights for Eardrum Bulging Detection | Tyto Care , Ltd. | 2026-03-17 | 330 | 0 |
| K254040 | LungFlow Basket Catheter | Free Flow Medical, Inc. | 2026-03-12 | 86 | 0 |
| DEN250012 | LifeVac | Lifevac, LLC | 2026-03-04 | 327 | 0 |
| K260003 | KARL STORZ Mediastinoscopes and Instruments | Karl Storz SE & CO. KG | 2026-03-02 | 59 | 0 |
| K253536 | Evala Nerve Stimulator (EPNR002) | Epineuron Technologies, Inc. | 2026-02-27 | 106 | 0 |
| K253612 | Acclarent AERA Eustachian Tube Balloon Dilation System | Acclarent, Inc. | 2026-02-19 | 93 | 0 |
| K251672 | NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ | Medtronic Xomed, Inc. | 2026-02-10 | 256 | 0 |
| K251790 | SeptAlign | Spirair, Inc. | 2026-01-16 | 219 | 0 |
| K252339 | iotaSOFT® Insertion System | Iotamotion, Inc. | 2026-01-09 | 165 | 0 |
| K251402 | LIA-1 Catheter (542-1) | Leadoptik, Inc. | 2025-12-19 | 227 | 0 |
| K250863 | FUJIFILM Ultrasonic Endoscope EB-710US | Fujifilm Corporation | 2025-12-12 | 266 | 0 |
| K251731 | KARL STORZ Flexible Intubation Video Endoscope – Sterile (FI | Karl Storz SE & CO. KG | 2025-12-05 | 182 | 0 |
| K252874 | Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 | Serpex Medical, Inc. | 2025-10-08 | 28 | 0 |
| K251208 | Tuned Self-Fitting Mobile App | Tuned , Ltd. | 2025-09-26 | 161 | 0 |
| K252921 | Radial Jaw 4 Pulmonary Biopsy Forceps | Boston Scientific Corporation | 2025-09-26 | 14 | 0 |
| K252045 | Ion Endoluminal System (IF1000) | Intuitive Surgical, Inc. | 2025-09-23 | 85 | 0 |
| K251894 | Himaging Bronchscope System | Himaging Technology (Shanghai) Co., Ltd. | 2025-09-23 | 95 | 0 |
| K252528 | Ion Endoluminal System (IF1000) | Intuitive Surgical, Inc. | 2025-09-05 | 25 | 0 |
| K250874 | Sunrise | Sunrise SA | 2025-08-29 | 158 | 0 |
| K251752 | Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, B | Shanghai AnQing Medical Instrument Co., Ltd. | 2025-08-27 | 79 | 0 |
| K241731 | Outlook Surgical Versa One System (8900139) | Resnent, LLC | 2025-08-11 | 420 | 0 |
| K251823 | UE BRONCHO Single-Use Bronchoscopes (EBS-380C); UE BRONCHO S | Zhejiang UE Medical Corp. | 2025-08-11 | 59 | 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