Cleared Traditional

K821497 - DISPOSABLE SURGICAL SCRUB BRUSHES

K821497 is an FDA 510(k) clearance for DISPOSABLE SURGICAL SCRUB BRUSHES, manufactured by Medical Systems Research. The device is a Class 1 General & Plastic Surgery device with product code GEC cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K821497 · Medical Systems Research · General & Plastic Surgery device
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Jul 1982
Decision
56d
Days
Class 1
Risk

K821497 is an FDA 510(k) clearance for the DISPOSABLE SURGICAL SCRUB BRUSHES. Classified as Brush, Scrub, Operating-room (product code GEC), Class I - General Controls.

Submitted by Medical Systems Research (Mchenry, US). The FDA issued a Cleared decision on July 14, 1982 after a review of 56 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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 Medical Systems Research devices

FDA 510(k) Submission Details - K821497

510(k) Number K821497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1982
Decision Date July 14, 1982
Days to Decision 56 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
59d faster than avg
Panel avg: 115d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

GEC Device Classification - Class 1, General Controls

Product Code GEC Brush, Scrub, Operating-room
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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 - GEC Brush, Scrub, Operating-room

All 24
Devices cleared under the same product code (GEC) and FDA review panel - the closest regulatory comparables to K821497.
MEDICAL PRODUCTS FOAM DOUBLE SCRUB #450
K831226 · Ballard Medical Products · May 1983
ARRIRM SCRUB BRUSH/SPONGE
K823173 · The Buckeye Cellulose Corp. · Nov 1982
SURGI-SCRUB V
K822865 · Acme United Corp. · Oct 1982
CURITY SURGICAL SCRUB BRUSH SPONGE
K820086 · The Kendal Co. · Jan 1982
DISPOSABLE SCRUB BRUSH
K810655 · Dexide, Inc. · May 1981
HEAVY DRAINAGE PACK
K803116 · American Medical Disposable, Inc. · Jan 1981