Cleared Traditional

K161570 - Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium, Theia NPWT Foam Wound Dressing Kit-Large (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K161570 · Lc Medical Concepts, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
83d
Days
Class 2
Risk

K161570 is an FDA 510(k) clearance for the Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-.... Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by Lc Medical Concepts, Inc. (Penfield, US). The FDA issued a Cleared decision on August 29, 2016 after a review of 83 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4780 - the FDA general and plastic surgery 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 Lc Medical Concepts, Inc. devices

Submission Details

510(k) Number K161570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2016
Decision Date August 29, 2016
Days to Decision 83 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 114d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OMP Negative Pressure Wound Therapy Powered Suction Pump
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4780
Definition For Wound Management Via Application Of Continual Or Intermittent Negative Pressure To The Wound For Removal Of Fluids, Including Wound Exudate, Irrigation Fluids, And Infectious Materials. The Device Is Indicated For Management Of Chronic, Acute, Traumatic, Subacute And Dehisced Wounds, Partial-thickness Burns, Ulcers (such As Diabetic Or Pressure), Flaps And Grafts.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - OMP Negative Pressure Wound Therapy Powered Suction Pump

All 208
Devices cleared under the same product code (OMP) and FDA review panel - the closest regulatory comparables to K161570.
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