Cleared Traditional

K801840 - SURGICAL BANDAGES/SUNLEEP DX

K801840 is an FDA 510(k) clearance for SURGICAL BANDAGES/SUNLEEP DX, manufactured by Martin'S Maine Exchange. The device is a Class 1 General & Plastic Surgery device with product code NAD cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K801840 · Martin'S Maine Exchange · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1980
Decision
39d
Days
Class 1
Risk

K801840 is an FDA 510(k) clearance for the SURGICAL BANDAGES/SUNLEEP DX. Classified as Dressing, Wound, Occlusive (product code NAD), Class I - General Controls.

Submitted by Martin'S Maine Exchange (Mchenry, US). The FDA issued a Cleared decision on September 9, 1980 after a review of 39 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 Martin'S Maine Exchange devices

FDA 510(k) Submission Details - K801840

510(k) Number K801840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1980
Decision Date September 09, 1980
Days to Decision 39 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
76d faster than avg
Panel avg: 115d · This submission: 39d
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 54
Devices cleared under the same product code (NAD) and FDA review panel - the closest regulatory comparables to K801840.
CHESEBROUGH-POND'S MULTILAYER ELASTIC
K823852 · Chesebrough-Pond'S U.S.A. Co. · Mar 1983
ADHESIVE WOUND COVER FILM
K822080 · Hollister, Inc. · Oct 1982
PEDIBAND CAT.#195-197
K802021 · Pollak (Intl.), Ltd. · Sep 1980
FIXOMULL STERILE
K800953 · Beiersdorf, Inc. · May 1980
AIRSTRIP THEATRE WARD DRESSING
K791369 · Acme United Corp. · Aug 1979