510(k) Report

Devices descending from K921707

258 later devices reach Pentax Naso-Pharyngo-Laryngoscope FNL-15P2/15RP2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K013591Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary EquipmentOlympus Optical Co., Ltd.2001176—
+1K011869Xenf-DP Rhino-Laryngofiberscope, Its Accessories and Ancillary EquipmentThe Olympus Optical Co.200182—
+1K992526Flexible Nasopharyngo-Laryngoscopes, Flexible BronchoscopeRichard Wolf Medical Instruments Corp.19993—
+1K964815AP-4000, Air Pulse Sensory StimulatorPentax Precision Instrument Corp.19971—
+2K252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DOlympus Medical Systems Corporation20260—
+2K200342Single Use Grasping Forceps FG-214P, Single Use Grasping Forceps FG-220P, Single Use…Olympus Medical Systems Corp.20200—
+2K190972Ambu aScope 4 RhinoLaryngo InterventionAmbu A/S20192—
+2K181286Ambu aScope RLS SlimAmbu A/S20186—
+2K181240Rhino-Laryngo Fiberscope Olympus ENF-GP2Olympus Medical Systems Corp.201811
+2K132039Ergo-Flex Laryngo-Nasopharyngoscope EF-N and EF-N SlimJedmed Instrument Co.20141—
+2K070580Nasopharyngoscope, BronchoscopeXion GmbH20070—
+2K070752Ksea Miniature Endoscope, Model 11565KARL STORZ Endoscopy-America, Inc.20076—
+2K052452Visera Rhino-Laryngovideoscope Olympus Enf Type VTOlympus Medical Systems Corporation2005159—
+2K040684T-Stat Microvascular Tissue Oximeter, Model 303Spectros Corporation200467—
+2K032092Olympus Xcyf-TP3 Cystofiberscope/NephrofiberscopeOlympus Optical Co., Ltd.20030—
+2K031790Slide-on Endosheath System for Sensory TestingVision-Sciences, Inc.20030—
+2K021073Visera Rhinlaryngovideoscope Olympus Enf Type VOlympus America, Inc.2002160—
+3K243639Portare System (FA-001)Grumpy Innovation, Inc.20250—
+3K230536Single-use Flexible Rhinolaryngoscope; Digital Video MonitorHunan Vathin Medical Instrument Co., Ltd.20230—
+3K221660Rhino-Laryngofiberscope Olympus Enf Type-XPOlympus Medical Systems Corp.202201
+3K221581Single-Use Flexible RhinolaryngoscopeHunan Vathin Medical Instrument Co., Ltd.20220—
+3K191080Ambu aScope 4 RhinoLaryngo SlimAmbu A/S20194—
+3K150248ORL Video NasoPharyngo-LarngoscopeJedmed Instrument Company20150—
+3K112826Noorvms-Oxy Tissue Oxygen and Temperture MonitorMoor Instruments, Ltd.20120—
+3K091452Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030)Cas Medical Systems, Inc.200957—
+3K083892Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030)Cas Medical Systems, Inc.200958—
+3K082569Entellus Medical Flexible Endoscope and EyepieceEntellus Medical, Inc.20085—
+3K081233T-Stat 303 Ischemia Monitoring SystemSpectros Corporation200856—
+3K073036Fore-Sight, MC-2000 SeriesCas Medical Systems, Inc.200859—
+3K061960Fore-Sight Cerebral Oximeter Monitor, Model 2040Cas Medical Systems, Inc.200659—
+3K061313Evis Exera 180 SystemOlympus Medical Systems Corporation2006158Class I
+3K051257Adult Cerebral Oximeter, Model 2040Cas Medical Systems, Inc.200563—
+3K031648Visera Rhino-Laryngovideoscope Olympus Enf Type VOlympus Optical Co., Ltd.2003159—
+4K253184Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic…Zhuhai Wesee Meditech Co., Ltd.20260—
+4K232435Rhinolaryngoscope systemShenzhen HugeMed Medical Technical Development Co., Ltd.20240—
+4K230280ANDORATE® Suction Valve and ANDORATE® Biopsy ValveGa Health Company Limited20230—
+4K220606Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2Ambu A/S202210—
+4K214050ENT Nasopharyngoscope and AccessoriesMedimaging Integrated Solution, Inc (Miis)20220—
+4K220004Zsquare ENT-Flex EndoscopeZsquare, Ltd.20220—
+4K192322T-Stat 2.0 Microvascular Tissue OximeterSpectros Corporation20190—
+4K183416Rhino-Laryngo Videoscope Olympus ENF-VT3Olympus Medical Systems Corp.201901
+4K182102Rhino-Laryngo Videoscope Olympus Enf-VH2, Rhino-Laryngo Videoscope Olympus Enf-V4Olympus Medical Systems Corp.20191—
+4K162151PENTAX Medical ENT Video Imaging SystemPentax of America, Inc.20176—
+4K1629163NT endoscopy system3nt Medical, Ltd.20173—
+4K131028Pentax Video Bronchoscopes (EB Family)Pentax Medical Company201436
+4K121959Evis Exera Iii Video SystemOlympus Medical Systems Corp.201314Class I
+4K111425Olympus LTF-S190-10, Olumpus Otv-S190, Olympus CLV-S190Olympus Medical Systems Corp.2012341
+4K102366Finess EndoscopeEntellus Medical, Inc.20110—
+4K094030Fore-Sight Absolute Cerebral and Somatic Oximeter, MC 2000 Series, Models MC2000…Cas Medical Systems, Inc.201053—
+4K102715Regional OximeterNonin Medical, Inc.201053—
+4K100584Evis Exeraii 180 SystemOlympus Medical Systems Corporation20101329
+4K082174Y-AdapterAsthmatx, Inc.20080—
+4K073407PacificaOr-Nim Medical, Ltd.20081—
+5K260503Triton 1 SystemNeptune Medical, Inc.20260—
+5K252341Evis Exera Iii Bronchovideoscope (Olympus BF-Q190); Evis Exera Iii Bronchovideoscope…Olympus Medical Systems Corp.20260—
+5K232043Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C…Guangzhou Red Pine Medical Instrument Co., Ltd.20240—
+5K2318541788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIMStryker20235—
+5K230332Ambu® aScope™ Colon; Ambu® aBox™ 2Ambu A/S20236—
+5K230588Aer-O-Scope Colonoscope SystemGi View, Ltd.20231—
+5K230428Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2Ambu A/S20234—
+5K222861EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100…Olympus Medical Systems Corporation20231—
+5K223299Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2…Ambu A/S202361
+5K223782Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler SetAmbu A/S20230—
+5K221638Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3Olympus Medical Systems Corp.20220—
+5K210052Saneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without…Saneso, Inc.20221—
+5K212382Ambu® aScope™ Gastro, Ambu® aBox™2Ambu A/S20222—
+5K210928PENTAX Medical Video Bronchoscope EB11-J10Pentax of America, Inc.20210—
+5K202727Peregrine Endoscopy System3nt Medical, Ltd.20210—
+5K201617TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control…Schoelly Fiberoptic GmbH20210—
+5K192704Endofresh Digestive Endoscopy SystemHuizhou Xzing Technology Co., Ltd.20200—
+5K200678PENTAX Medical Video Bronchoscope EB-J10 SeriesPentax of America, Inc.20200—
+5K201098Ambu Duodeno SystemAmbu Innovation GmbH20202—
+5K193026Visera Elite II Video System Center, Visera Elite II Endoeye 3DOlympus Medical Systems Corp.20205—
+5K192305Colibri Endoscopy System3nt Medical, Ltd.20200—
+5K190449Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head…Olympus Medical Systems Corp.20195—
+5K183691PENTAX Medical ENT Video Imaging SystemPentax of America, Inc.20192—
+5K190560SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI…Nonin Medical, Inc.20190—
+5K173921HD-500 Video Endoscope SystemSonoscape Medical Corp.20182—
+5K172726EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433DOlympus Medical Systems Corp.201872
+5K172156PENTAX Medical EPK-3000 Video Imaging SystemPentax Medical20183—
+5K173554PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and…Pentax of America, Inc.20180—
+5K173085invendoscopy E210 SystemInvendo Medical GmbH20180—
+5K161355invendoscopy E200 SystemInvendo Medical GmbH20161—
+5K143727PENTAX Medical EKP-i5010 Video Processor with EB FamilyPentax of America, Inc.20153—
+5K151011Visera 4K Uhd SystemOlympus Medical Systems Corp.20153—
+5K151305SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model…Nonin Medical, Inc.20151—
+5K140149Epx-4440HD Digital Video ProcessorFujifilm Medical Systems U.S.A, Inc.201416—
+5K133879Fore-Sight Elite Absolute Tissue OximeterCas Medical Systems, Inc.201444—
+5K131902Pentax Video Upper G.I. Scopes (EG Family)Pentax Medical Company2014102
+5K131855Pentax Video Colonoscopes (EC Family)Pentax Medical Company2014136
+5K132402Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc.201431
+5K131422Peerscope SystemEndochoice, Inc.20132—
+5K123700Fore-Sight Elite Absolute Tissue OximeterCas Medical Systems, Inc.20130—
+5K122470Pentax Epk-I5010 Video ProcessorPentax Medical20136—
+5K123365Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190Olympus Medical Systems Corp.201319—
+5K123317Evis Exera Iii Gastrointestinal Videoscope Olympus GIXP190NOlympus Medical Systems Corporation20120—
+5K113120CHF-Y0005Olympus Medical Systems Corp.20120—
+5K113215Model 7600 Regional Oximeter System with Equanox TechnologyNonin Medical, Inc.201242—
+5K111756V1 SystemOlympus Medical Systems Corp.201202
+5K112680Evis Exera Iii Video SystemOlympus Medical Systems Corporation2012576