Cleared Traditional

K895920 - VITAPATCH PIN PROTECTION DEVICE FOR PER...

K895920 is an FDA 510(k) clearance for VITAPATCH PIN PROTECTION DEVICE FOR PER..., manufactured by Vitaphore Corp.. The device is a Class 1 General & Plastic Surgery device with product code KGX cleared through the Traditional 510(k) pathway after a 603-day FDA review.

K895920 · Vitaphore Corp. · General & Plastic Surgery device
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Jun 1991
Decision
603d
Days
Class 1
Risk

K895920 is an FDA 510(k) clearance for the VITAPATCH PIN PROTECTION DEVICE FOR PERCUTANEOUS. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Vitaphore Corp. (Menlo Park, US). The FDA issued a Cleared decision on June 6, 1991 after a review of 603 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5240 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Vitaphore Corp. devices

FDA 510(k) Submission Details - K895920

510(k) Number K895920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1989
Decision Date June 06, 1991
Days to Decision 603 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
488d slower than avg
Panel avg: 115d · This submission: 603d
Pathway characteristics
Predicate-based equivalence.

KGX Device Classification - Class 1, General Controls

Product Code KGX Tape And Bandage, Adhesive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5240
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 - KGX Tape And Bandage, Adhesive

All 84
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K895920.
3M WATER DISPERSIBLE ADHESIVE TAPE, 98XX
K912520 · 3M Health Care, Ltd. · Jul 1991
AIRSTRIP FIRST AID & POST-OP DRESSING
K911682 · Smith & Nephew United, Inc. · Jul 1991
QUALTEX ISLAND DRESSING
K910657 · Deroyal Industries, Inc. · Jul 1991
TRO-GARD
K910678 · Conmedcorp · May 1991
ELASTIC ADHESIVE BANDAGE
K910436 · Byron Medical · Mar 1991
ELASTOPLAST
K904500 · Beiersdorf, Inc. · Nov 1990