Cleared Traditional

ASHERMAN CHEST BANDAGE (K942757) - FDA 510(k) Clearance

K942757 · Asherman Medical Products, LLC · General & Plastic Surgery device
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Aug 1994
Decision
52d
Days
-
Risk

K942757 is an FDA 510(k) clearance for the ASHERMAN CHEST BANDAGE. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Asherman Medical Products, LLC (San Antonio, US). The FDA issued a Cleared decision on August 1, 1994 after a review of 52 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 Asherman Medical Products, LLC devices

Submission Details

510(k) Number K942757 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 10, 1994
Decision Date August 01, 1994
Days to Decision 52 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
63d faster than avg
Panel avg: 115d · This submission: 52d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MGP Dressing, Wound And Burn, Occlusive
Device Class -