Cleared Traditional

K822865 - SURGI-SCRUB V

K822865 is the FDA 510(k) clearance for SURGI-SCRUB V by Acme United Corp.. It is a Class 1 General & Plastic Surgery device (product code GEC) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K822865 · Acme United Corp. · General & Plastic Surgery device
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Oct 1982
Decision
21d
Days
Class 1
Risk

K822865 is an FDA 510(k) clearance for the SURGI-SCRUB V. Classified as Brush, Scrub, Operating-room (product code GEC), Class I - General Controls.

Submitted by Acme United Corp. (Mchenry, US). The FDA issued a Cleared decision on October 18, 1982 after a review of 21 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 Acme United Corp. devices

Submission Details

510(k) Number K822865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1982
Decision Date October 18, 1982
Days to Decision 21 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
94d faster than avg
Panel avg: 115d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 18
Devices cleared under the same product code (GEC) and FDA review panel - the closest regulatory comparables to K822865.
STERILE SURGICAL SCRUB BRUSH
K874653 · Surgikos, Inc. · Dec 1987
PHARMASEAL SCRUB CARE-SURGICAL SCRUB BRUSH SPONGES
K854232 · American Pharmaseal Div. Ahsc · Dec 1985
SCRUB MATE DRY STERILE SCRUB BRUSH
K844411 · American Sterilizer Co. · Dec 1984
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