Cleared Traditional

K181428 - Clyra Wound Irrigation Solution

K181428 · Clyra Medical Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2019
Decision
476d
Days
-
Risk

K181428 is an FDA 510(k) clearance for the Clyra Wound Irrigation Solution. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Clyra Medical Technologies, Inc. (Westminster, US). The FDA issued a Cleared decision on September 20, 2019 after a review of 476 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 Clyra Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K181428

510(k) Number K181428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2018
Decision Date September 20, 2019
Days to Decision 476 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
361d slower than avg
Panel avg: 115d · This submission: 476d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Consultant

Rhodes & Associates, Inc.
Tanya Rhodes

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 225
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