Cleared Traditional

SERAGARD INJECTION PATCH (K001240) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K001240 · Platinum Services, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
64d
Days
Class 1
Risk

K001240 is an FDA 510(k) clearance for the SERAGARD INJECTION PATCH. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Platinum Services, Inc. (Dequincy, US). The FDA issued a Cleared decision on June 21, 2000 after a review of 64 days - a notably fast clearance cycle.

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: 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 Platinum Services, Inc. devices

Submission Details

510(k) Number K001240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2000
Decision Date June 21, 2000
Days to Decision 64 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
51d faster than avg
Panel avg: 115d · This submission: 64d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 20
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K001240.
STERILE PLASTIC DRESSING
K944588 · Smith & Nephew, Inc. · Nov 1994
PROMEON HYDROGEL DRESSING #45 NONSTERILE W/ MESH
K915358 · Medtronic Vascular · Apr 1992
3M FIRST AID BANDAGE FOR MINOR WOUNDS
K901777 · 3M Company · Aug 1990
TEGADERM BRAND TRANSPARENT DRESSING SERIES 16XX
K901845 · 3M Company · Jul 1990
MODIFIED SUTURE USED IN CATHETER INSERTION TRAYS
K892450 · Quinton, Inc. · Oct 1989
DERMASTRIP
K883660 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1989