Cleared Traditional

K914207 - CLEARSITE(R) STERILE WOUND CARE DRESSING

K914207 is an FDA 510(k) clearance for CLEARSITE STERILE WOUND CARE DRESSING, manufactured by Ndm Acquisition Corp.. The device is a Class 1 General & Plastic Surgery device with product code NAE cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K914207 · Ndm Acquisition Corp. · General & Plastic Surgery device
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Oct 1991
Decision
34d
Days
Class 1
Risk

K914207 is an FDA 510(k) clearance for the CLEARSITE(R) STERILE WOUND CARE DRESSING. Classified as Dressing, Wound, Hydrogel Without Drug And/or Biologic (product code NAE), Class I - General Controls.

Submitted by Ndm Acquisition Corp. (Dayton, US). The FDA issued a Cleared decision on October 23, 1991 after a review of 34 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 Ndm Acquisition Corp. devices

FDA 510(k) Submission Details - K914207

510(k) Number K914207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1991
Decision Date October 23, 1991
Days to Decision 34 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
81d faster than avg
Panel avg: 115d · This submission: 34d
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 19
Devices cleared under the same product code (NAE) and FDA review panel - the closest regulatory comparables to K914207.
PROMEON HYDROGEL DRESSING #45 STERILE W/O MESH
K915357 · Medtronic Vascular · May 1992
PROMEON HYDROGEL DRESSING #45 STERILE W/ MESH
K915359 · Medtronic Vascular · May 1992
DEROYAL HYDROGEL DRESSING
K915182 · Deroyal Industries, Inc. · Apr 1992
LOMATUELL OINTMENT DRESSING
K802793 · Secol Co. · Dec 1980