Cleared Traditional

DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM (K970721) - FDA 510(k) Clearance

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

K970721 · Johnson & Johnson Medical, Inc. · General & Plastic Surgery device
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Mar 1997
Decision
22d
Days
Class 2
Risk

K970721 is an FDA 510(k) clearance for the DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM. Classified as Wound Dressing Kit (product code MCY), Class II - Special Controls.

Submitted by Johnson & Johnson Medical, Inc. (Arlington, US). The FDA issued a Cleared decision on March 21, 1997 after a review of 22 days - a notably fast clearance 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: 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 Johnson & Johnson Medical, Inc. devices

Submission Details

510(k) Number K970721 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 27, 1997
Decision Date March 21, 1997
Days to Decision 22 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
93d faster than avg
Panel avg: 115d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.