Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
ETN · Predicate Candidate Screening
97 FDA 510(k) clearances under this product code; the 50 most recent screened below.
115 daysmedian FDA review time
278 days90th percentile
97clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253536 | Evala Nerve Stimulator (EPNR002) | Epineuron Technologies, Inc. | 2026-02-27 | 106 | 0 |
| K251672 | NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ | Medtronic Xomed, Inc. | 2026-02-10 | 256 | 0 |
| K242852 | ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D | Inomed Medizintechnik GmbH | 2025-06-13 | 266 | 0 |
| K233001 | Bioscope Neuromonitor Device | Biosys Biyomedikal Muhendislik San. VE Tic. A.S. | 2024-12-13 | 448 | 0 |
| K241917 | EARP Nerve Cuff Electrode | Retropsoas Technologies, LLC | 2024-07-31 | 30 | 0 |
| K232888 | Disposable Laryngeal Electrodes | Suzhou Haishen Medical Device Associates Co., Ltd. | 2023-12-21 | 94 | 0 |
| K230320 | NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinf | Medtronic Xomed, Inc. | 2023-10-26 | 262 | 0 |
| K230853 | EARP Nerve Cuff Electrode | Nvision Biomedical Technologies, Inc. | 2023-10-06 | 192 | 0 |
| K231580 | NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35 | Medtronic Xomed, Inc. | 2023-08-30 | 91 | 0 |
| K223254 | C2 Xplore | Inomed Medizintechnik GmbH | 2023-01-27 | 98 | 0 |
| K212164 | Mapping Suction Probe | Inomed Medizintechnik GmbH | 2022-11-11 | 487 | 0 |
| K213246 | NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Pr | Medtronic Xomed, Inc. | 2022-03-21 | 172 | 0 |
| K212355 | Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint | Checkpoint Surgical | 2021-08-26 | 28 | 2 |
| K200886 | StimSite | Allotrope Medical, Inc. | 2020-11-10 | 222 | 0 |
| K152769 | FREMAP ELECTRODE | Ad-Tech Medical Instrument Corporation | 2016-05-06 | 224 | 0 |
| K152505 | C2 NerveMonitor System | Inomed Medizintechnik GmbH | 2016-02-01 | 152 | 0 |
| K150005 | Checkpoint, Checkpoint Head & Neck | Ndi Medical, LLC | 2015-02-19 | 48 | 0 |
| K133348 | STIM PROBE | Spes Medica Srl | 2014-11-21 | 387 | 0 |
| K140400 | ES2 NEUROMONITORING ACCESSORY INSTRUMENTS | Stryker Corporation | 2014-07-01 | 133 | 0 |
| K122040 | INVOTEC LARYNGEAL ELECTRODE | Invotec International, Inc. | 2013-10-31 | 476 | 0 |
| K121931 | NONDISPOSABLE STIMULATING INSTRUMENTS | Neurovision Medical Products, Inc. | 2012-10-19 | 109 | 0 |
| K121257 | LARYNGEAL ELECTRODE | Technomed Europe | 2012-08-28 | 124 | 0 |
| K112686 | NEXT GEN EMG ENDOTRACHEAL TUBE | Medtronic Xomed, Inc. | 2012-06-27 | 286 | 2 |
| K112717 | NUVASIVE NVJJB SYSTEM | Nuvasive, Inc. | 2012-04-13 | 207 | 0 |
| K112426 | XIAN FRIENDSHIP DISPOSABLE NERVE STIMULATOR PROBES | Xian Friendship Medical Electronics Co., Ltd. | 2012-04-02 | 223 | 0 |
| K112718 | NUVASIVE NVM5 SYSTEM | Nuvasive, Inc. | 2012-03-16 | 179 | 0 |
| K112709 | STIMULATION/DISSECTION INSTRUMENTS | Nu Vasive, Incorporated | 2012-02-09 | 143 | 0 |
| K111671 | SEASPINE MONOPOLAR PROBE SYSYEM | Seaspine, Inc. | 2011-12-28 | 196 | 0 |
| K110989 | NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE | Neurovision Medical Products, Inc. | 2011-11-03 | 209 | 1 |
| K111597 | DISPOSABLE STIMULATING ELECTRODE | Nuvasive, Inc. | 2011-10-13 | 127 | 0 |
| K112435 | RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT | Rhythmlink International, LLC | 2011-09-22 | 29 | 0 |
| K110696 | NEURO CHECK DEVICE WITH IO-FLEX WIRE | Baxano, Inc. | 2011-07-07 | 115 | 0 |
| K110712 | DRYTOUCH SUCTION STIMULATOR PROBE | Neurovision Medical Products, Inc. | 2011-06-28 | 106 | 0 |
| K110422 | SURGICAL STIMULATORS | Technomed Europe | 2011-05-26 | 101 | 1 |
| K110138 | PAIRED HYDROGEL ELECTRODE | Neurovision Medical Products, Inc. | 2011-04-08 | 80 | 0 |
| K103128 | CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH | Cadwell Lab, Inc. | 2011-02-23 | 121 | 0 |
| K102862 | NEUROVISION SE (NERVEANA) | Neurovision Medical Products, Inc. | 2010-12-21 | 82 | 0 |
| K100992 | NEURALMAS | Innovative Surgical Solutions, LLC ("Iss") | 2010-09-24 | 168 | 0 |
| K093373 | LARYNGEAL SURFACE ELECTRODE | Spes Medica Srl | 2010-08-24 | 299 | 0 |
| K091874 | INOMED ADHESIVE LARYNGEAL ELECTRODES, MODELS 530655, 530656 | Inomed Medizintechnik GmbH | 2009-11-18 | 148 | 0 |
| K092292 | CHECKPOINT | Ndi Medical, LLC | 2009-10-28 | 91 | 0 |
| K092729 | BAXANO NEURO CHECK DEVICE | Baxano, Inc. | 2009-10-02 | 28 | 0 |
| K083242 | NEUROSIGN AVALANCHE MOTOR NERVE MONITOR | The Magstim Company , Ltd. | 2009-07-29 | 268 | 0 |
| K090838 | STIMULUS/DISSECTION INSTRUMENTS | Axon Systems, Inc. | 2009-07-20 | 115 | 0 |
| K081742 | BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25 | Baxano, Inc. | 2008-09-17 | 90 | 0 |
| K072736 | RHYTHMLINK INTERNATIONAL MONOPOLAR STIMULATING INSTRUMENT | Rhythmlink International, LLC | 2008-01-22 | 117 | 1 |
| K071349 | NEUROSIGN LARYNGEAL ELECTRODES | The Magstim Company , Ltd. | 2007-12-12 | 212 | 0 |
| K063560 | HILGER DUAL-STIM NERVE STIMULATOR | Wr Medical Electronics Co. | 2007-01-05 | 38 | 0 |
| K063305 | STIMULATING BUR GUARD | Medtronic Xomed, Inc. | 2006-11-29 | 28 | 0 |
| K062549 | XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 1052 | Excel Tech. , Ltd. | 2006-10-04 | 35 | 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