Cleared Special

K251156 - NPseal (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K251156 · Guard Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
30d
Days
Class 2
Risk

K251156 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 May 15, 2025 after a review of 30 days - a notably fast clearance cycle.

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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Guard Medical, Inc. devices

Submission Details

510(k) Number K251156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2025
Decision Date May 15, 2025
Days to Decision 30 days
Submission Type Special
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
84d faster than avg
Panel avg: 114d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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.