Part 874 Subpart B—Diagnostic Devices
FDA submissions for Part 874 Subpart B—Diagnostic Devices in the Ear, Nose, Throat (EN) review panel, including product codes, regulations, and recent device decisions.
Section range: §§ 874.1050–874.1925
CFR Part: 874
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| EWO | Audiometer | 874.1050 | 2 | 235 |
| LYN | Apparatus, Visual Reinforcement Audiometric | 874.1050 | 2 | 3 |
| EWC | Chamber, Acoustic (For Audiometric Testing) | 874.1060 | 1 | 2 |
| ETR | Adaptor, Short Increment Sensitivity Index (Sisi) | 874.1070 | 1 | 0 |
| EWA | Set, Audiometer Calibration | 874.1080 | 1 | 2 |
| ETY | Tester, Auditory Impedance | 874.1090 | 2 | 70 |
| NAS | Tympanometer | 874.1090 | 2 | 2 |
| PTO | Tester, Auditory Impedance, Exempt | 874.1090 | 2 | 0 |
| PTP | Tympanometer, Exempt | 874.1090 | 2 | 0 |
| ETT | Cushion, Earphone (For Audiometric Testing) | 874.1100 | 1 | 0 |
| ETS | Generator, Electronic Noise (For Audiometric Testing) | 874.1120 | 2 | 5 |
| KLX | Electroglottograph | 874.1325 | 2 | 4 |
| ETM | Gustometer, Sterile | 874.1500 | 1 | 0 |
| NNJ | Gustometer, Non-Sterile | 874.1500 | 1 | 0 |
| NRK | Kit, Test, Olfactory | 874.1600 | 2 | 1 |
| ETP | Stimulator, Caloric-Water | 874.1800 | 1 | 6 |
| KHH | Stimulator, Caloric-Air | 874.1800 | 1 | 7 |
| ETN | Stimulator, Nerve | 874.1820 | 2 | 97 |
| PDQ | Neurosurgical Nerve Locator | 874.1820 | 2 | 34 |
| QWP | Optical Neurosurgical Nerve Locator | 874.1820 | 2 | 1 |
| ETK | Tube, Toynbee Diagnostic | 874.1925 | 1 | 1 |
Recent Devices
| Record | Device | Applicant | Decision Date |
|---|---|---|---|
| K253536 | Evala Nerve Stimulator (EPNR002) | Epineuron Technologies, Inc. | Feb 27, 2026 |
| K251672 | NIM Essence EMG Endotracheal Tube (NIMEID060); NIM Essence EMG Endotracheal Tube (NIMEID065); NIM Essence EMG Endotracheal Tube (NIMEID070); NIM Essence EMG Endotracheal Tube (NIMEID075); NIM Essence EMG Endotracheal Tube (NIMEID080) | Medtronic Xomed, Inc. | Feb 10, 2026 |
| K243636 | Neuralytix iD3 System (NTX-9001) | Neuralytix, LLC | Jun 26, 2025 |
| K242852 | ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847) | Inomed Medizintechnik GmbH | Jun 13, 2025 |
| K233001 | Bioscope Neuromonitor Device | Biosys Biyomedikal Muhendislik San. VE Tic. A.S. | Dec 13, 2024 |
| K241917 | EARP Nerve Cuff Electrode | Retropsoas Technologies, LLC | Jul 31, 2024 |
| K234095 | OtoNova/OtoNova Pro | Otodynamics | Jun 21, 2024 |
| K240430 | Otoport Pro | Otodynamics, Ltd. | Mar 15, 2024 |
| K232888 | Disposable Laryngeal Electrodes | Suzhou Haishen Medical Device Associates Co., Ltd. | Dec 21, 2023 |
| K231545 | hearOAE | Hearx SA (Pty) , Ltd. | Oct 27, 2023 |
| K230320 | NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube | Medtronic Xomed, Inc. | Oct 26, 2023 |
| K230853 | EARP Nerve Cuff Electrode | Nvision Biomedical Technologies, Inc. | Oct 6, 2023 |
| K231580 | NIM 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) | Medtronic Xomed, Inc. | Aug 30, 2023 |
| K222106 | Waypoint GPS | Waypoint Orthopedics, Inc. | May 12, 2023 |
| K223438 | TELIGEN System Peripheral Motor Nerve Stimulation Indications | Medos International SARL | Feb 10, 2023 |
| K223254 | C2 Xplore | Inomed Medizintechnik GmbH | Jan 27, 2023 |
| K212164 | Mapping Suction Probe | Inomed Medizintechnik GmbH | Nov 11, 2022 |
| K221821 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | Sep 23, 2022 |
| K213345 | Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE | Path Medical GmbH | Jun 22, 2022 |
| K220160 | PediGuard Threaded | Spineguard S.A. | Mar 31, 2022 |
| K213246 | NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long | Medtronic Xomed, Inc. | Mar 21, 2022 |
| K212355 | Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large | Checkpoint Surgical | Aug 26, 2021 |
| K203684 | Neurosign V4 Intraoperative Nerve Monitor | Magstim Company, Ltd. | Mar 17, 2021 |
| K201454 | DSG Connect Technology | Spineguard S.A. | Feb 10, 2021 |
| K200886 | StimSite | Allotrope Medical, Inc. | Nov 10, 2020 |
| K191723 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | Oct 18, 2019 |
| K190163 | ALARA Neuro Access Kit | SurGenTec, LLC | Jul 16, 2019 |
| K191372 | Lyra | Interacoustics A/S | Jul 15, 2019 |
| K182617 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | May 9, 2019 |
| K182662 | NAV PAK Needle, NIM NAV PAK Needle | Boston Endo Surgical Tech, | Apr 10, 2019 |
| K183201 | Hearing Healthcare Pro | Db Diagnostic Systems, Inc. | Mar 6, 2019 |
| K181559 | Neurosign V4 Intraoperative Nerve Monitor | Magstim Company, Ltd. | Nov 9, 2018 |
| K180542 | NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe | Boston Endo Surgical Tech, | Aug 22, 2018 |
| K180287 | GSI Corti | Grason-Stadler, Inc. | May 11, 2018 |
| K173526 | SENTIO MMG Gen 2 | Medos International SARL | Apr 5, 2018 |
| K173134 | SENTIO MMG Pedicle Access Needles | Medos International SARL | Mar 22, 2018 |
| K173567 | Sera | Interacoustics A/S | Feb 14, 2018 |
| K172403 | GSI Novus | Grason-Stadler, Inc. | Oct 20, 2017 |
| K171506 | Easyscreen | Maico Diagnostics GmbH | Aug 29, 2017 |
| K171038 | Hearing Healthcare Pro | Db Diagnostic Systems, Inc. | Aug 2, 2017 |
| K171265 | Otowave 302 Portable Tympanometer | Amplivox, Ltd. | Jul 28, 2017 |
| K171807 | ES2 Neuromonitoring Accessory Instruments | Stryker Corporation | Jul 18, 2017 |
| K162313 | NuVasive Next Generation NVM5 System | Nu Vasive, Incorporated | Mar 16, 2017 |
| K162210 | touchTymp | Maico Diagnostics GmbH | Nov 16, 2016 |
| K161893 | Neuromonitoring Kit | SI-BONE, Inc. | Oct 18, 2016 |
| K161707 | Madsen Zodiac | Gn Otometrics | Sep 1, 2016 |
| K152747 | DSG Threaded Drill System | Spineguard S.A. | Jun 10, 2016 |
| K152769 | FREMAP ELECTRODE | Ad-Tech Medical Instrument Corporation | May 6, 2016 |
| K152505 | C2 NerveMonitor System | Inomed Medizintechnik GmbH | Feb 1, 2016 |
| K152942 | NuVasiveNVM5 System | Nu Vasive, Incorporated | Jan 13, 2016 |
| K151025 | iHearTest | Ihear Medical, Inc. | Dec 29, 2015 |
| K151616 | AT235 | Interacoustics A/S | Jul 15, 2015 |
| K151509 | GSI TympStar Pro Middle Ear Analyzer | Diagnostic Group, Dba Grason-Stadler | Jun 25, 2015 |
| K150163 | Otowave 202 Portable Tympanometer | Amplivox, Ltd. | Apr 23, 2015 |
| K143641 | NuVasive NVM5 System | Nu Vasive, Incorporated | Mar 27, 2015 |
| K150491 | ER36 Series OAE Test System | Etymotic Research, Inc. | Mar 26, 2015 |
| K141524 | NEURO-AUDIO | Teleemg, LLC USA | Mar 12, 2015 |
| K142438 | Nerve Monitoring Cable System | Pioneer Surgical Technology, Inc. (Rti Surgical, Inc.) | Mar 5, 2015 |
| K143395 | Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit | Otodynamics, Ltd. | Feb 23, 2015 |
| K150005 | Checkpoint, Checkpoint Head & Neck | Ndi Medical, LLC | Feb 19, 2015 |
| K143159 | Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard Needle 120mm, Cannulated PediGuard Handle; PediGuard Tri Tip Ø4.0mm, PediGuard Tri Tip Ø3.2mm, PediGuard Tri Tip Ø2.5mm, PediGuard Ø2.5mm XS, PediGuard Curv, PediGuard Curv XS | Spineguard S.A. | Jan 23, 2015 |
| K133348 | STIM PROBE | Spes Medica Srl | Nov 21, 2014 |
| K141968 | NUVASIVE NVM5 SYSTEM | Nuvasive, Inc. | Nov 14, 2014 |
| K140088 | PHANTOM XL INSULATED DILATORS | Tedan Surgical Innovations, LLC | Sep 25, 2014 |
| K140400 | ES2 NEUROMONITORING ACCESSORY INSTRUMENTS | Stryker Corporation | Jul 1, 2014 |
| K133012 | SENTIERO | Path Medical GmbH | Jun 9, 2014 |
| K131304 | SENTIO MMG | Innovative Surgical Solutions, LLC ("Iss") | May 29, 2014 |
| K132694 | NUVASIVE NVM5 SYSTEM | Nu Vasive, Incorporated | May 16, 2014 |
| K133530 | NUVASIVE EMG ENDOTRACHEAL TUBE | Nu Vasive, Incorporated | May 2, 2014 |
| K132138 | RHYTHMLINK DISPOSABLE CONCENTRIC STIMULATING PROBE | Rhythmlink International, LLC | Apr 11, 2014 |
| K132373 | BIOMET ACCESS SYSTEM | Biomet Spine (Aka Ebi, LLC) | Mar 27, 2014 |
| K133013 | INVENTIS MIDDLE EAR ANALYZER, FLUTE BASIC, INVENTIS MIDDLE EAR ANALYZER, FLUTE PLUS, INVENTIS MIDDLE EAR ANALYZER, FLUTE | Inventis S.R.L. | Jan 24, 2014 |
| K122040 | INVOTEC LARYNGEAL ELECTRODE | Invotec International, Inc. | Oct 31, 2013 |
| K123390 | PEDIGUARD NERVE DETECTOR SYSTEM | Spineguard S.A. | Aug 8, 2013 |
| K130806 | NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE | Neurovision Medical Products, Inc. | Jul 12, 2013 |
| K130795 | TITAN | Interacoustics A/S | Jun 20, 2013 |
| K120590 | DILATOR TUBE SET | Koros USA, Inc. | May 7, 2013 |
| K123307 | NUVASIVE NVM5 SYSTEM | Nuvasive, Inc. | Apr 23, 2013 |
| K123624 | OTOSTAT DPOAE + MEPA MEASUREMENT SYSTEM | Mimosa Acoustics, Inc. | Mar 28, 2013 |
| K123589 | CADWELL DISPOSABLE PROBE HANDLE | Cadwell | Mar 19, 2013 |
| K121847 | TITAN | Interacoustics A/S | Nov 29, 2012 |
| K122496 | AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM | Bio-Logic Systems Corp. | Nov 1, 2012 |
| K121931 | NONDISPOSABLE STIMULATING INSTRUMENTS | Neurovision Medical Products, Inc. | Oct 19, 2012 |
| K121257 | LARYNGEAL ELECTRODE | Technomed Europe | Aug 28, 2012 |
| K121512 | SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM | Bio-Logic Systems Corp. | Jul 26, 2012 |
| K112686 | NEXT GEN EMG ENDOTRACHEAL TUBE | Medtronic Xomed, Inc. | Jun 27, 2012 |
| K112992 | EARLOGIC OAE TESTER | Earlogic Corporation | Apr 20, 2012 |
| K112717 | NUVASIVE NVJJB SYSTEM | Nuvasive, Inc. | Apr 13, 2012 |
| K112426 | XIAN FRIENDSHIP DISPOSABLE NERVE STIMULATOR PROBES | Xian Friendship Medical Electronics Co., Ltd. | Apr 2, 2012 |
| K112247 | A BAER WITH ABAER I/O FUNCTION | Natus Medical Incorporated | Apr 2, 2012 |
| K112718 | NUVASIVE NVM5 SYSTEM | Nuvasive, Inc. | Mar 16, 2012 |
| K112709 | STIMULATION/DISSECTION INSTRUMENTS | Nu Vasive, Incorporated | Feb 9, 2012 |
| K111671 | SEASPINE MONOPOLAR PROBE SYSYEM | Seaspine, Inc. | Dec 28, 2011 |
| K111618 | AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION | Natus Medical Incorporated | Dec 28, 2011 |
| K112733 | ER35 ERO-SCAN PRO HEARING TEST SYSTEM | Etymotic Research, Inc. | Dec 16, 2011 |
| K110989 | NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE | Neurovision Medical Products, Inc. | Nov 3, 2011 |
| K111597 | DISPOSABLE STIMULATING ELECTRODE | Nuvasive, Inc. | Oct 13, 2011 |
| K112435 | RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT | Rhythmlink International, LLC | Sep 22, 2011 |
| K110696 | NEURO CHECK DEVICE WITH IO-FLEX WIRE | Baxano, Inc. | Jul 7, 2011 |
| K110712 | DRYTOUCH SUCTION STIMULATOR PROBE | Neurovision Medical Products, Inc. | Jun 28, 2011 |
