Cleared Traditional

K233001 - Bioscope Neuromonitor Device (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K233001 · Biosys Biyomedikal Muhendislik San. VE Tic. A.S. · Ear, Nose, Throat device
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Dec 2024
Decision
448d
Days
Class 2
Risk

K233001 is an FDA 510(k) clearance for the Bioscope Neuromonitor Device. Classified as Stimulator, Nerve (product code ETN), Class II - Special Controls.

Submitted by Biosys Biyomedikal Muhendislik San. VE Tic. A.S. (Ankara, TR). The FDA issued a Cleared decision on December 13, 2024 after a review of 448 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1820 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ear, Nose, Throat submissions.

View all Biosys Biyomedikal Muhendislik San. VE Tic. A.S. devices

Submission Details

510(k) Number K233001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2023
Decision Date December 13, 2024
Days to Decision 448 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
359d slower than avg
Panel avg: 89d · This submission: 448d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ETN Stimulator, Nerve
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1820
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - ETN Stimulator, Nerve

All 96
Devices cleared under the same product code (ETN) and FDA review panel - the closest regulatory comparables to K233001.
Evala Nerve Stimulator (EPNR002)
K253536 · Epineuron Technologies, Inc. · Feb 2026
NIM Essence™ EMG Endotracheal Tube (NIMEID060)
K251672 · Medtronic Xomed, Inc. · Feb 2026
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)
K242852 · Inomed Medizintechnik GmbH · Jun 2025
EARP Nerve Cuff Electrode
K241917 · Retropsoas Technologies, LLC · Jul 2024
Disposable Laryngeal Electrodes
K232888 · Suzhou Haishen Medical Device Associates Co., Ltd. · Dec 2023
NIM Standard Reinforced EMG Endotracheal Tube
K230320 · Medtronic Xomed, Inc. · Oct 2023