Cleared Traditional

K895654 - SORBEX(TM) SOFT SPONGE

K895654 is an FDA 510(k) clearance for SORBEX(TM) SOFT SPONGE, manufactured by Fountain Pharmaceuticals, Inc.. The device is a Class 1 General & Plastic Surgery device with product code NAD cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K895654 · Fountain Pharmaceuticals, Inc. · General & Plastic Surgery device
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Feb 1990
Decision
153d
Days
Class 1
Risk

K895654 is an FDA 510(k) clearance for the SORBEX(TM) SOFT SPONGE. Classified as Dressing, Wound, Occlusive (product code NAD), Class I - General Controls.

Submitted by Fountain Pharmaceuticals, Inc. (Knoxville, US). The FDA issued a Cleared decision on February 20, 1990 after a review of 153 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4020 - 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 Fountain Pharmaceuticals, Inc. devices

FDA 510(k) Submission Details - K895654

510(k) Number K895654 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 20, 1989
Decision Date February 20, 1990
Days to Decision 153 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 115d · This submission: 153d
Pathway characteristics
Predicate-based equivalence.

NAD Device Classification - Class 1, General Controls

Product Code NAD Dressing, Wound, Occlusive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4020
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - NAD Dressing, Wound, Occlusive

All 56
Devices cleared under the same product code (NAD) and FDA review panel - the closest regulatory comparables to K895654.
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2018 ARTERIAL/VENOUS PRESSURE DRESSING
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HYPAFIX DRESSING RETENTION SHEET
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DUODERM* TRANSPARENT HYDROCOLLOID DRESSING-MODIFY
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