Cleared Traditional

K940694 - XEROFORM PETROLATUM DRESSING

K940694 · Medtrax Industries, Inc. · General & Plastic Surgery device
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Mar 1994
Decision
42d
Days
-
Risk

K940694 is an FDA 510(k) clearance for the XEROFORM PETROLATUM DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Medtrax Industries, Inc. (Longwood, US). The FDA issued a Cleared decision on March 30, 1994 after a review of 42 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 Medtrax Industries, Inc. devices

FDA 510(k) Submission Details - K940694

510(k) Number K940694 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 16, 1994
Decision Date March 30, 1994
Days to Decision 42 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
73d faster than avg
Panel avg: 115d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 594
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K940694.
SALINE DRESSING
K952948 · Busse Hospital Disposables, Inc. · Aug 1995
HOLLISTER HYDROCOLLOID WOUND DRESSINGS
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PREPPIES SKIN BARRIER WIPE
K945675 · Kendall Healthcare Products Co. Div.Of Tyco Health · Feb 1995
SPYROFILM IQ WOUND DRESSING(WITH INERT FILLER)
K932676 · Polymedica Industries, Inc. · Dec 1993
SALINE WET DRESSING- STERILE
K934258 · Trinity Laboratories, Inc. · Nov 1993
DERMAGRAN WOUND DRESSING
K924754 · Derma Sciences, Inc. · May 1993