Cleared Traditional

K230148 - Vlab (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K230148 · Dormotech Medical, Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2023
Decision
265d
Days
Class 2
Risk

K230148 is an FDA 510(k) clearance for the Vlab. Classified as Amplifier, Physiological Signal (product code GWL), Class II - Special Controls.

Submitted by Dormotech Medical, Ltd. (Afula, IL). The FDA issued a Cleared decision on October 11, 2023 after a review of 265 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1835 - the FDA neurology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Dormotech Medical, Ltd. devices

Submission Details

510(k) Number K230148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2023
Decision Date October 11, 2023
Days to Decision 265 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
117d slower than avg
Panel avg: 148d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWL Amplifier, Physiological Signal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1835
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 Neurology devices follow this clearance model.

Regulatory Consultant

ProMedic Consulting, LLC
Paul Dryden

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GWL Amplifier, Physiological Signal

All 52
Devices cleared under the same product code (GWL) and FDA review panel - the closest regulatory comparables to K230148.
Delphi Amplifier
K243746 · Quantalx Neroscience · Mar 2025
NExT Station
K242832 · Eb Neuro S.P.A. · Dec 2024
DreamClear
K240646 · Somnomed Technologies Inc., Doing Business AS Remware · Sep 2024
BE Plus PRO, Neurotravel LIGHT
K242305 · Eb Neuro S.P.A. · Sep 2024
X-trodes System M
K232210 · X-Trodes · Feb 2024
SomniCheck
K223676 · Brainmatterz, LLC · Jun 2023