Devices descending from K023984
350 later devices reach Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160… through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +4 | K250232 | Vathin® Video Bronchoscope System | Hunan Vathin Medical Instrument Co., Ltd. | 2025 | 0 | — |
| +4 | K250862 | Evis Exera Iii Bronchovideoscope (Olympus BF-XP190); Evis Exera Iii Bronchovideoscope… | Olympus Medical Systems Corp. | 2025 | 0 | Class I |
| +4 | K250957 | Disposable Biopsy Forceps (FB-211D); Disposable Biopsy Forceps (FB-221D); Disposable… | Olympus Medical Systems Corporation | 2025 | 0 | — |
| +4 | K242793 | Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0… | Shenzhen Insighters Medical Technology Co., Ltd. | 2025 | 0 | — |
| +4 | K242067 | Visera Elite Iii Video System Center Olympus Otv-S700; Visera Elite Iii Led Light Source… | Olympus Corporations of the Americas | 2025 | 2 | — |
| +4 | K242416 | Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11… | Hunan Vathin Medical Instrument Co., Ltd. | 2025 | 0 | — |
| +4 | K242110 | PENTAX Medical Video Colonoscope (EC38-i20cWL) | Pentax of America, Inc. | 2025 | 0 | — |
| +4 | K242535 | Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01… | Hunan Vathin Medical Instrument Co., Ltd. | 2024 | 0 | — |
| +4 | K241213 | PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope… | Pentax of America, Inc. | 2024 | 0 | — |
| +4 | K241612 | Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L… | Hunan Vathin Medical Instrument Co., Ltd. | 2024 | 0 | — |
| +4 | K240849 | Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse… | Ambu A/S | 2024 | 0 | — |
| +4 | K240227 | LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1) | Lina Medical Aps | 2024 | 0 | — |
| +4 | K233630 | Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse… | Ambu A/S | 2024 | 1 | — |
| +4 | K232997 | EVIS Exera III Gastrointestinal Videoscope GIF-1TH190 | Olympus Medical Systems Corporation | 2024 | 1 | 2 |
| +4 | K234113 | MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus… | Medimaging Integrated Solution, Inc (Miis) | 2024 | 0 | — |
| +4 | K233886 | Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2 | Ambu A/S | 2024 | 1 | — |
| +4 | K233779 | LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C)… | MacroLux Medical Technology Co., Ltd. | 2024 | 0 | — |
| +4 | K232919 | Ambu® aScope™ Gastro Large; Ambu® aBox™ 2 | Ambu A/S | 2024 | 1 | — |
| +4 | K233327 | 1788 4K Camera System with Advanced Imaging Modality | Stryker Endoscopy | 2024 | 1 | — |
| +4 | K233671 | Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aView™ 2 Advance | Ambu A/S | 2024 | 2 | — |
| +4 | K231118 | Cystoscope System | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2023 | 0 | — |
| +4 | K223926 | VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box | Medimaging Integrated Solution, Inc (Miis) | 2023 | 0 | — |
| +4 | K232582 | Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set | Ambu A/S | 2023 | 1 | 1 |
| +4 | K231249 | PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope… | Pentax of America, Inc. | 2023 | 1 | 4 |
| +4 | K230948 | BFlex™ 2 Slim 3.8 Single-Use Bronchoscope | Verathon Medical (Canada) Ulc | 2023 | 2 | — |
| +4 | K222910 | Bronchoscope System | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2023 | 0 | — |
| +4 | K222173 | Saneso Lens Wash Bottle Assembly (SAN-LWB-A) | Saneso, Inc. | 2023 | 0 | — |
| +4 | K213235 | PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System | Pentax of America, Inc. | 2022 | 1 | — |
| +4 | K221642 | SIRIUS Endoscope System | Precision Robotics (Hong Kong) Limited | 2022 | 1 | — |
| +4 | K221580 | Single-Use Flexible Cystoscope | Hunan Vathin Medical Instrument Co., Ltd. | 2022 | 0 | — |
| +4 | K220465 | PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT… | Pentax of America, Inc. | 2022 | 1 | — |
| +4 | K222162 | Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) | Shanghai AnQing Medical Instrument Co., Ltd. | 2022 | 1 | — |
| +4 | K222602 | Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope… | Zhuhai Pusen Medical Technology Co., Ltd. | 2022 | 1 | — |
| +4 | K213782 | Single-Use Video Bronchoscopes, Digital Controller | Micro-Tech (Nanjing) Co., Lts | 2022 | 0 | — |
| +4 | K220399 | WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope… | OTU Medical, Inc. | 2022 | 0 | — |
| +4 | K212202 | WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope… | OTU Medical, Inc. | 2022 | 1 | — |
| +4 | K211882 | HD-550 Video Endoscope System | Sonoscape Medical Corp. | 2022 | 1 | — |
| +4 | K211169 | Bronchoscope System | Shanghai AnQing Medical Instrument Co., Ltd. | 2021 | 2 | — |
| +4 | K210177 | PENTAX Medical Video Upper GI Scopes EG17-J10 | Pentax of America, Inc. | 2021 | 0 | — |
| +4 | K212201 | PENTAX Medical Auto Leakage Tester SHA-P6 | Pentax of America, Inc. | 2021 | 0 | — |
| +4 | K201832 | Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 | Olympus Medical Systems Corp. | 2021 | 0 | 1 |
| +4 | K211030 | EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope… | Boston Scientific Corporation | 2021 | 1 | — |
| +4 | K210883 | aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8 | Ambu A/S | 2021 | 2 | — |
| +4 | K210485 | PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC… | Pentax of America, Inc. | 2021 | 0 | 2 |
| +4 | K203128 | Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound… | Olympus Medical Systems Corp. | 2020 | 1 | — |
| +4 | K202180 | Broncoflex Agile; Product Reference: 20030001 , Broncoflex Vortex; Product Reference… | Axess Vision Technology | 2020 | 1 | — |
| +4 | K200216 | 4K UHD Camera System | Scivita Medical Technology Co., Ltd. | 2020 | 0 | — |
| +4 | K201200 | Visera Elite II Video System Center | Olympus Medical Systems Corp. | 2020 | 4 | — |
| +4 | K200542 | Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video… | Olympus Medical Systems Corp. | 2020 | 0 | — |
| +4 | K200397 | Single Use Biopsy Forceps FB-456D | Olympus Medical Systems Corp. | 2020 | 0 | — |
| +4 | K192164 | Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR | Olympus Medical Systems Corp. | 2020 | 1 | — |
| +4 | K191828 | Vathin Video Bronchoscope System | Hunan Vathin Medical Instrument Co., Ltd. | 2020 | 8 | — |
| +4 | K190805 | PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope… | Pentax of America, Inc. | 2019 | 1 | — |
| +4 | K190799 | PENTAX Medical Video Upper GI Scopes (EG Family) | Pentax of America, Inc. | 2019 | 0 | — |
| +4 | K191282 | PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family | Pentax of America, Inc. | 2019 | 0 | 1 |
| +4 | K183675 | 3D Visualization System | Scivita Medical Technology Co., Ltd. | 2019 | 0 | — |
| +4 | K183525 | EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F | Olympus Medical Systems Corp. | 2019 | 2 | 1 |
| +4 | K183419 | EVIS EXERA III Bronchovideoscope Olympus BF-XT190 | Olympus Medical Systems Corp. | 2019 | 2 | Class I |
| +4 | K182825 | FUJIFILM Ultrasonic Endoscope | Fujifilm Corporation | 2019 | 0 | — |
| +4 | K181084 | PENTAX Video Colonoscopes (EC Family) | Pentax of America, Inc. | 2019 | 3 | 2 |
| +4 | K182846 | PENTAX Medical EPK-3000 Video Imaging System | Pentax of America, Inc. | 2019 | 2 | — |
| +4 | K180285 | PENTAX Medical Video Colonoscope EC34-i10T Series | Pentax Medical of America, Inc. | 2018 | 0 | — |
| +4 | K180292 | PENTAX Video Upper G.I. Scope EG34-i10 | Pentax Medical of America, Inc. | 2018 | 0 | — |
| +4 | K173679 | PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes | Pentax of America, Inc. | 2018 | 2 | — |
| +4 | K180414 | EPX-4440FN Digital Video Processor with Light Source | Fujifilm New Development U.S.A., Inc. | 2018 | 0 | — |
| +4 | K172796 | Flex Robotic System and Flex Transabdominal Drive | Medrobotics Corporation | 2018 | 0 | — |
| +4 | K172844 | Cellvizio 100 Series System with Confocal Miniprobes | Mauna Kea Technologies | 2017 | 6 | — |
| +4 | K172817 | 4K Camera Head Olympus CH-S400-XZ-EB, 4K Autoclavable Camera Head Olympus CH-S400-XZ-EA | Olympus Medical Systems Corp. | 2017 | 0 | — |
| +4 | K163675 | Processor VP-7000, Light Source BL-7000 | Fujifilm Medical System U.S.A., Inc. | 2017 | 12 | — |
| +4 | K162836 | FUJIFILM Surgical System | Fujifilm New Development U.S.A., Inc. | 2017 | 8 | — |
| +4 | K160098 | Single Use Aspiration Needle NA-U401SX | Olympus Medical Systems Corp. | 2016 | 1 | 2 |
| +4 | K150831 | Cellvizio 100 Series System with Confocal Miniprobes | Mauna Kea Technologies | 2015 | 7 | — |
| +4 | K152182 | Fuse Gastroscopy System | Endochoice, Inc. | 2015 | 1 | — |
| +4 | K150618 | PENTAX Medical EPK-i7010 Video Processor with GI Family | Pentax of America, Inc. | 2015 | 3 | — |
| +4 | K150525 | SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link | KARL STORZ Endoscopy-America, Inc. | 2015 | 7 | — |
| +4 | K151315 | Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle | Boston Scientific Corporation | 2015 | 3 | — |
| +4 | K151895 | Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle | Boston Scientific Corporation | 2015 | 0 | — |
| +4 | K150221 | EPX-4440HD and EPX-4400HD with FICE | Fujifilm Medical System U.S.A., Inc. | 2015 | 0 | — |
| +4 | K142909 | Flexible 19G EBUS Needle | Spiration, Inc. | 2015 | 7 | — |
| +4 | K142922 | SpyGlass DS Direct Visualization System | Boston Scientific Corporation | 2015 | 9 | 1 |
| +4 | K141358 | Cellvizio 100 Series with System Confocal Miniprobes | Mauna Kea Technologies | 2014 | 9 | — |
| +4 | K132389 | Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and… | Daniel & Daniel Consulting | 2014 | 10 | — |
| +4 | K131780 | Evis Exera Iii Video System | Olympus Medical Systems Corp. | 2013 | 7 | 8 |
| +4 | K122831 | Video System Center | Olympus Medical Systems Corp. | 2012 | 19 | — |
| +4 | K121449 | Directpath | Cybernet Systems Co., Ltd. | 2012 | 0 | — |
| +4 | K112051 | Lungpoint Planning and Virtual Bronchoscopic Navigation (VBN) Software | Broncus Technologies, Inc. | 2011 | 3 | — |
| +4 | K093195 | Echotip Ultra Endobronchial High Definition Ultasound Needle, Model: Echo-HD-22-Ebus-O | Cook Ireland, Ltd. | 2010 | 8 | — |
| +4 | K093423 | Lungpoint Procedure Planning | Broncus Technologies, Inc. | 2009 | 1 | — |
| +4 | K091257 | Medi-Globe Sonotip II Ebus-Tbna Needle System | Medi-Globe Corporation | 2009 | 3 | — |
| +4 | K081518 | Ultrasound Video Bronchoscope, Model EB-1970UK | Pentax Medical Company | 2008 | 5 | — |
| +4 | K062315 | Superdimension/Bronchus Premium 2 | Superdimension, Ltd. | 2006 | 54 | 1 |
| +5 | K261637 | Single-use Flexible Bronchoscope | Hunan Vathin Medical Instrument Co., Ltd. | 2026 | 0 | — |
| +5 | K260309 | Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5… | Ambu A/S | 2026 | 0 | — |
| +5 | K262079 | 4K Camera Head OLYMPUS CH-S700-08-LB | Olympus Medical Systems Corp. | 2026 | 0 | — |
| +5 | K260401 | Evis Eus Ultrasound Bronchofibervideoscope Olympus BF-UCP190F (BF-UCP190F) | Olympus Medical Systems Corporation | 2026 | 0 | — |
| +5 | K254153 | Single-use Video Scope; PB Digital Controller | Mirco-Tech (Nanjing) Co., Ltd. | 2026 | 0 | — |
| +5 | K251861 | FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM… | Fujifilm Corporation | 2026 | 0 | — |
| +5 | K260185 | 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with… | Stryker Endoscopy | 2026 | 0 | — |
| +5 | K251336 | VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light… | Olympus Medical Systems Corp. | 2025 | 0 | — |
| +5 | K251986 | Auxiliary Water Tube Maj-855 | Olympus Medical Systems Corporation | 2025 | 0 | — |