Cleared Traditional

K242290 - DormoTech NLab (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence.

K242290 · Dormotech Medical, Ltd. · Neurology device
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Jan 2025
Decision
159d
Days
Class 2
Risk

K242290 is an FDA 510(k) clearance for the DormoTech NLab. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Dormotech Medical, Ltd. (Afula, IL). The FDA issued a Cleared decision on January 8, 2025 after a review of 159 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 868.2375 - 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 K242290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2024
Decision Date January 08, 2025
Days to Decision 159 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
11d slower than avg
Panel avg: 148d · This submission: 159d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MNR Ventilatory Effort Recorder
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. 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.

Clinical Evidence

ClinicalTrials.gov
NCT06224972 Completed Observational Industry-sponsored

Evaluation of the Usability and Performance Assessment of the DormoTech VLAB Device as a Home Sleep Test

Usability and Performance Assessment of DormoTech VLAB

47
Patients (actual)
1
Site
Condition studied Sleep Disorder
Eligibility All sexes · 22 Years+
Principal investigator Benjamin D Fox, MD
Sponsor Dormotech Medical (industry)
Started 2023-06-13 → Primary completion 2023-08-12
Primary outcome
AHI Score and Classification
Secondary outcome
Total Sleep Time (min)
Study completed - no results published. This trial concluded in 2023 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov