Cleared Traditional

K212971 - NPseal (FDA 510(k) Clearance)

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

K212971 · Guard Medical, Inc. · General & Plastic Surgery device
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Feb 2022
Decision
146d
Days
Class 2
Risk

K212971 is an FDA 510(k) clearance for the NPseal. Classified as Negative Pressure Wound Therapy Non-powered Suction Apparatus (product code OKO), Class II - Special Controls.

Submitted by Guard Medical, Inc. (Miami, US). The FDA issued a Cleared decision on February 10, 2022 after a review of 146 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4683 - 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 Guard Medical, Inc. devices

Submission Details

510(k) Number K212971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2021
Decision Date February 10, 2022
Days to Decision 146 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
32d slower than avg
Panel avg: 114d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OKO Negative Pressure Wound Therapy Non-powered Suction Apparatus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4683
Definition A Non-powered Suction Apparatus Indicated For Negative Pressure Wound Therapy (npwt) That Is Intended 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.
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

AlvaMed, Inc.
Eric Bannon

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.