Cleared Traditional

K113032 - SNAP WOUND CARE SYSTEM (FDA 510(k) Clearance)

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

K113032 · Spiracur, Inc. · General & Plastic Surgery device
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Dec 2011
Decision
50d
Days
Class 2
Risk

K113032 is an FDA 510(k) clearance for the SNAP WOUND CARE SYSTEM. Classified as Negative Pressure Wound Therapy Non-powered Suction Apparatus (product code OKO), Class II - Special Controls.

Submitted by Spiracur, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on December 1, 2011 after a review of 50 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. 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 Spiracur, Inc. devices

Submission Details

510(k) Number K113032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2011
Decision Date December 01, 2011
Days to Decision 50 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
64d faster than avg
Panel avg: 114d · This submission: 50d
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.