Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EOQ — Predicate Candidate Screening
241 FDA 510(k) clearances under this product code; the 50 most recent screened below.
94 daysmedian FDA review time
262 days90th percentile
241clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260382 | MONARCH™ Platform (MON-000008) | Auris Health, Inc. | 2026-07-25 | 170 | 0 |
| K254037 | LungFlow Airway Catheter | Free Flow Medical, Inc. | 2026-07-10 | 206 | 0 |
| K253137 | FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model E | Fujifilm Corporation | 2026-06-16 | 264 | 0 |
| K260565 | SmartClip Delivery Catheter (ADR-1715) | Elucent Medical | 2026-05-14 | 84 | 0 |
| K252341 | EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXE | Olympus Medical Systems Corp. | 2026-04-23 | 269 | 0 |
| K260420 | LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B | MacroLux Medical Technology Co., Ltd. | 2026-04-08 | 58 | 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 |
| 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 |
| K251752 | Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, B | Shanghai AnQing Medical Instrument Co., Ltd. | 2025-08-27 | 79 | 0 |
| K251823 | UE BRONCHO Single-Use Bronchoscopes (EBS-380C); UE BRONCHO S | Zhejiang UE Medical Corp. | 2025-08-11 | 59 | 0 |
| K250232 | Vathin® Video Bronchoscope System | Hunan Vathin Medical Instrument Co., Ltd. | 2025-07-25 | 179 | 0 |
| K250862 | EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EX | Olympus Medical Systems Corp. | 2025-06-23 | 94 | 4 |
| K244017 | FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000 | Fujifilm Corporation | 2025-06-13 | 168 | 0 |
| K250118 | Disposable Balloon Catheter B5-2C | Olympus Medical Systems Corporation | 2025-06-04 | 139 | 0 |
| K250957 | Disposable Biopsy Forceps (FB-211D); Disposable Biopsy Force | Olympus Medical Systems Corporation | 2025-05-30 | 60 | 0 |
| K243497 | Portable Video Processor (EA101), Flexible Bronchoscope BS41 | Shanghai AnQing Medical Instrument Co., Ltd. | 2025-05-29 | 198 | 0 |
| K242793 | Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral | Shenzhen Insighters Medical Technology Co., Ltd. | 2025-05-28 | 254 | 0 |
| K243541 | LumiRex Bronchoscope | Contra Healthcare Solutions, LLC | 2025-04-30 | 166 | 0 |
| K250210 | Broncho Videoscope System (Single-use Broncho Videoscope (SB | Scivita Medical Technology Co., Ltd. | 2025-03-19 | 54 | 0 |
| K242010 | Bronchoscope System, The Single-use Bronchoscope (Single-use | Shenzhen Sanping Image Technology Co., Ltd. | 2025-03-14 | 247 | 0 |
| K242324 | DUTAU-NOVATECH® | Novatech SA | 2025-02-06 | 184 | 0 |
| K243219 | MONARCH™ Platform (MON-000008) | Auris Health, Inc. | 2025-01-23 | 108 | 1 |
| K242416 | Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C | Hunan Vathin Medical Instrument Co., Ltd. | 2025-01-16 | 154 | 0 |
| K241612 | Video Bronchoscope System; Single-use Flexible Bronchoscope | Hunan Vathin Medical Instrument Co., Ltd. | 2024-10-29 | 146 | 0 |
| K240289 | Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, | Scivita Medical Technology Co., Ltd. | 2024-10-23 | 265 | 0 |
| K242070 | Ion Endoluminal System (IF 1000) | Intuitive Surgical, Inc. | 2024-09-24 | 70 | 0 |
| K232601 | BroncTru™ Transbronchial Access Tool | Broncus Medical, Inc. | 2024-05-31 | 277 | 0 |
| K234113 | MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System | Medimaging Integrated Solution, Inc (Miis) | 2024-05-01 | 126 | 0 |
| K232038 | BioStar Single Use Transbronchial Aspiration Needle | Broncus Medical, Inc. | 2024-04-26 | 291 | 0 |
| K233779 | LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38 | MacroLux Medical Technology Co., Ltd. | 2024-04-05 | 130 | 0 |
| K240135 | Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) ( | Intuitive Surgical, Inc. | 2024-04-03 | 76 | 0 |
| K231107 | Bronchoscope System | Hunan Endoso Life Technology Co., Ltd. | 2024-02-15 | 302 | 0 |
| K240075 | FUJIFILM Endoscope Model EB-710XT | FUJIFILM Healthcare Americas Corporation | 2024-02-07 | 28 | 0 |
| K232860 | PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Vi | Pentax of America, Inc. | 2024-01-18 | 125 | 0 |
| K231970 | PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTA | Pentax of America, Inc. | 2024-01-12 | 193 | 0 |
| K233671 | Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 2.7 | Ambu A/S | 2024-01-04 | 50 | 0 |
| K232984 | Ion Endoluminal System (IF1000) | Intuitive Surgical, Inc. | 2023-12-18 | 87 | 0 |
| K231521 | Broncho Videoscope System | Scivita Medical Technology Co., Ltd. | 2023-11-14 | 172 | 0 |
| K232582 | Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set | Ambu A/S | 2023-09-20 | 26 | 1 |
| K230428 | Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2 | Ambu A/S | 2023-08-10 | 174 | 0 |
| K222861 | EVIS XI Video System Center Olympus CV-1500, Bronchovideosco | Olympus Medical Systems Corporation | 2023-06-15 | 266 | 0 |
| K223299 | Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho | Ambu A/S | 2023-06-01 | 217 | 1 |
| K223836 | Vathin® Video Bronchoscope System | Hunan Vathin Medical Instrument Co., Ltd. | 2023-05-15 | 144 | 0 |
| K230948 | BFlex™ 2 Slim 3.8 Single-Use Bronchoscope | Verathon Medical (Canada) Ulc | 2023-05-03 | 29 | 0 |
| K222910 | Bronchoscope System | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2023-04-11 | 197 | 0 |
| K221340 | iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod | Boston Scientific Corporation | 2023-03-02 | 297 | 0 |
| K223144 | Galaxy System | Noah Medical Corp. | 2023-03-01 | 148 | 5 |
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