Cleared Traditional

K905519 - MONTROSE DRESSING APPLICATORS

K905519 is an FDA 510(k) clearance for MONTROSE DRESSING APPLICATORS, manufactured by Olemunda Pty , Ltd.. The device is a Class 1 General & Plastic Surgery device with product code NAD cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K905519 · Olemunda Pty , Ltd. · General & Plastic Surgery device
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Mar 1991
Decision
89d
Days
Class 1
Risk

K905519 is an FDA 510(k) clearance for the MONTROSE DRESSING APPLICATORS. Classified as Dressing, Wound, Occlusive (product code NAD), Class I - General Controls.

Submitted by Olemunda Pty , Ltd. (Evans City, US). The FDA issued a Cleared decision on March 6, 1991 after a review of 89 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4020 - 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 Olemunda Pty , Ltd. devices

FDA 510(k) Submission Details - K905519

510(k) Number K905519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1990
Decision Date March 06, 1991
Days to Decision 89 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
26d faster than avg
Panel avg: 115d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

NAD Device Classification - Class 1, General Controls

Product Code NAD Dressing, Wound, Occlusive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4020
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 - NAD Dressing, Wound, Occlusive

All 56
Devices cleared under the same product code (NAD) and FDA review panel - the closest regulatory comparables to K905519.
OTOSILK
K952203 · Boston Medical Products, Inc. · Jul 1995
MEDLINE STERILE GAUZE SPONGES
K930697 · Medline Industries, Inc. · Jun 1993
FRASTEC DRYNET, BRIDAL VEIL, VARIOUS SIZES
K912022 · Fraass Survival Systems, Inc. · Aug 1991
MODIFIED LABELING FOR BIOCLUSIVE* TRANS FILM DRESS
K901853 · Johnson & Johnson Medical, Inc. · Jan 1991
TENSOPLUS LITE
K901378 · Smith & Nephew United, Inc. · Jun 1990
2018 ARTERIAL/VENOUS PRESSURE DRESSING
K895845 · Advance Medical Designs, Inc. · Nov 1989