Cleared Traditional

AQUACEL SURGICAL PREP PADS (K854344) - FDA 510(k) Clearance

K854344 · Advanced Ortho-Technology, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1985
Decision
15d
Days
-
Risk

K854344 is an FDA 510(k) clearance for the AQUACEL SURGICAL PREP PADS. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Advanced Ortho-Technology, Inc. (Tuckahoe, US). The FDA issued a Cleared decision on November 13, 1985 after a review of 15 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 Advanced Ortho-Technology, Inc. devices

Submission Details

510(k) Number K854344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1985
Decision Date November 13, 1985
Days to Decision 15 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
100d faster than avg
Panel avg: 115d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 169
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K854344.
NON-ADHERING DRESSING WITH POVIDONE-IODINE
K861384 · Johnson & Johnson Professionals, Inc. · Jul 1986
BARD ABSORPTION DRESSING
K861024 · C.R. Bard, Inc. · Apr 1986
ACTISORB ACTIVATED CHARCOAL DRESSING
K860486 · Johnson & Johnson Professionals, Inc. · Mar 1986
TEGADERM PLUS TRANSPARENT DRESSING #952X
K852750 · 3M Company · Sep 1985
BAND-AID BRAND ADHESIVE BANDAGES
K852545 · Johnson & Johnson Professionals, Inc. · Sep 1985
BARD OCCLUSIVE WOUND DRESSING
K850889 · C.R. Bard, Inc. · Jul 1985