Cleared Traditional

K972646 - AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES

K972646 is an FDA 510(k) clearance for AD-HEAL HYDROGEL DRESSING, manufactured by Ludlow Technical Products. The device is a Class 1 General & Plastic Surgery device with product code NAE cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K972646 · Ludlow Technical Products · General & Plastic Surgery device
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Aug 1997
Decision
37d
Days
Class 1
Risk

K972646 is an FDA 510(k) clearance for the AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES. Classified as Dressing, Wound, Hydrogel Without Drug And/or Biologic (product code NAE), Class I - General Controls.

Submitted by Ludlow Technical Products (Chicopee, US). The FDA issued a Cleared decision on August 21, 1997 after a review of 37 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4022 - 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 Ludlow Technical Products devices

FDA 510(k) Submission Details - K972646

510(k) Number K972646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1997
Decision Date August 21, 1997
Days to Decision 37 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 115d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

NAE Device Classification - Class 1, General Controls

Product Code NAE Dressing, Wound, Hydrogel Without Drug And/or Biologic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4022
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 - NAE Dressing, Wound, Hydrogel Without Drug And/or Biologic

All 13
Devices cleared under the same product code (NAE) and FDA review panel - the closest regulatory comparables to K972646.
COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903)
K971597 · Coloplast Corp. · Jul 1997
HYDROGEL SKIN DRESSING
K962352 · North American Sterilization & Packaging Co. · Aug 1996
AQUAFLO HYDROGEL WOUND DRESSING & PACKER
K952945 · Sherwood Medical Co. · Aug 1995
CURAGEL HYDROGEL WOUND DRESSING
K950412 · Kendall Healthcare Products Co. Div.Of Tyco Health · Mar 1995
INTRASITE
K942748 · Smith & Nephew United, Inc. · Jun 1994
ALLEVYN ISLAND WOUND DRESSING
K935705 · Smith & Nephew United, Inc. · Feb 1994