Cleared Traditional

Theia NPWT Foam Wound Dressing Kit (K211277) - FDA 510(k) Clearance

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

K211277 · Clear Choice Therapeutics, Inc. · General & Plastic Surgery device
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Dec 2021
Decision
233d
Days
Class 2
Risk

K211277 is an FDA 510(k) clearance for the Theia NPWT Foam Wound Dressing Kit. Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by Clear Choice Therapeutics, Inc. (Athens, US). The FDA issued a Cleared decision on December 16, 2021 after a review of 233 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Clear Choice Therapeutics, Inc. devices

Submission Details

510(k) Number K211277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2021
Decision Date December 16, 2021
Days to Decision 233 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
118d slower than avg
Panel avg: 115d · This submission: 233d
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 Consultant

DuVal & Associates, P.A.
Kathy Herzog

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 - OMP Negative Pressure Wound Therapy Powered Suction Pump

All 92
Devices cleared under the same product code (OMP) and FDA review panel - the closest regulatory comparables to K211277.
PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Packs
K211318 · Smith & Nephew Medical Limited · Jan 2022
Tzoar 207 Negative Pressure Wound Therapy (NPWT) System
K202898 · Lightstone Medical Products (Ningbo) Co, Ltd. · Dec 2021
3M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit: VFCCC05MD, Large Dressing Kit: VFCCC05LG)
K211521 · 3M Healthcare Business Group · Dec 2021
Innomed NPWT Silicone Foam Dressing
K202823 · Zhejiang Longterm Medical Technology Co., Ltd. · Dec 2021
V.A.C.ULTA Negative Pressure Wound Therapy System
K203316 · Kci, A Part of 3M Health Care Business Group · Oct 2021
Dermatac™ Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology-Small (5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Small (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology - Medium(5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Medium (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology- Large (5 pac
K212320 · 3M Healthcare Business Group · Sep 2021