Cleared Traditional

Roosin Xeroform Petrolatum Dressing (K181478) - FDA 510(k) Clearance

K181478 · Roosin Medical Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2019
Decision
465d
Days
-
Risk

K181478 is an FDA 510(k) clearance for the Roosin Xeroform Petrolatum Dressing. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Roosin Medical Co., Ltd. (Taizhou, CN). The FDA issued a Cleared decision on September 13, 2019 after a review of 465 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 General & Plastic Surgery submissions.

View all Roosin Medical Co., Ltd. devices

Submission Details

510(k) Number K181478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2018
Decision Date September 13, 2019
Days to Decision 465 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
350d slower than avg
Panel avg: 115d · This submission: 465d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Consultant

Manton Business and Technology Services, LLC
Charles Shen

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 - FRO Dressing, Wound, Drug

All 168
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