Cleared Traditional

K921347 - CEPTI-SEAL DRESSING CHANGE KIT FOR VENOUS CATHETER

K921347 is an FDA 510(k) clearance for CEPTI-SEAL DRESSING CHANGE KIT FOR VENO..., manufactured by Medi-Flex Hospital Products, Inc.. The device is a Class 2 General & Plastic Surgery device with product code MCY cleared through the Traditional 510(k) pathway after a 296-day FDA review.

K921347 · Medi-Flex Hospital Products, Inc. · General & Plastic Surgery device
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Jan 1993
Decision
296d
Days
Class 2
Risk

K921347 is an FDA 510(k) clearance for the CEPTI-SEAL DRESSING CHANGE KIT FOR VENOUS CATHETER. Classified as Wound Dressing Kit (product code MCY), Class II - Special Controls.

Submitted by Medi-Flex Hospital Products, Inc. (Overland Park, US). The FDA issued a Cleared decision on January 8, 1993 after a review of 296 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5075 - 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 Medi-Flex Hospital Products, Inc. devices

FDA 510(k) Submission Details - K921347

510(k) Number K921347 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received March 18, 1992
Decision Date January 08, 1993
Days to Decision 296 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
181d slower than avg
Panel avg: 115d · This submission: 296d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MCY Device Classification - Class 2, Special Controls

Product Code MCY Wound Dressing Kit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5075
Definition This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.
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 Peers - MCY Wound Dressing Kit

All 12
Devices cleared under the same product code (MCY) and FDA review panel - the closest regulatory comparables to K921347.
DRESSING CHANGE TRAY-MODIFIED
K931932 · Medsurg Industries, Inc. · Aug 1993
TPN TRAY (STERILE)
K925021 · Customed, Inc. · Jun 1993
PER-Q-CATH DRESSING CHANGE TRAY
K926063 · Gesco Intl., Inc. · Jun 1993
PRESSURE SORE MANAGEMENT KIT
K912116 · Medical Device Inspection Co., Inc. · Oct 1991
LACERATION TRAY
K912117 · Medical Device Inspection Co., Inc. · Aug 1991
MEGA DRESSING CHANGE KIT
K910363 · Megadyne Medical Products, Inc. · Mar 1991