Cleared Traditional

K230142 - Epi-Stop Nasal Gel/epistaxis pack (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K230142 · Biomed Ent, Inc. · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Mar 2023
Decision
63d
Days
Class 1
Risk

K230142 is an FDA 510(k) clearance for the Epi-Stop Nasal Gel/epistaxis pack. Classified as Splint, Intranasal Septal (product code LYA), Class I - General Controls.

Submitted by Biomed Ent, Inc. (San Antonio, US). The FDA issued a Cleared decision on March 22, 2023 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4780 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biomed Ent, Inc. devices

Submission Details

510(k) Number K230142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2023
Decision Date March 22, 2023
Days to Decision 63 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
26d faster than avg
Panel avg: 89d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYA Splint, Intranasal Septal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4780
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

Biomed Elements B.V.
Marcela Garcia

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.