Cleared Traditional

K242758 - Atrauman® Ag (FDA 510(k) Clearance)

K242758 · Hartmann USA, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Dec 2024
Decision
88d
Days
-
Risk

K242758 is an FDA 510(k) clearance for the Atrauman® Ag. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Hartmann USA, Inc. (Rock Hill, US). The FDA issued a Cleared decision on December 9, 2024 after a review of 88 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 Hartmann USA, Inc. devices

Submission Details

510(k) Number K242758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2024
Decision Date December 09, 2024
Days to Decision 88 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 114d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Consultant

Qserve Group US
Lorry Weaver

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.

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