Cleared Traditional

K843636 - FOAM CARE ONE STEP PREP

K843636 is an FDA 510(k) clearance for FOAM CARE ONE STEP PREP, manufactured by Ballard Medical Products. The device is a Class 1 General & Plastic Surgery device with product code GEC cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K843636 · Ballard Medical Products · General & Plastic Surgery device
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Nov 1984
Decision
60d
Days
Class 1
Risk

K843636 is an FDA 510(k) clearance for the FOAM CARE ONE STEP PREP. Classified as Brush, Scrub, Operating-room (product code GEC), Class I - General Controls.

Submitted by Ballard Medical Products (Midvale, US). The FDA issued a Cleared decision on November 16, 1984 after a review of 60 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 Ballard Medical Products devices

FDA 510(k) Submission Details - K843636

510(k) Number K843636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1984
Decision Date November 16, 1984
Days to Decision 60 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 115d · This submission: 60d
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 20
Devices cleared under the same product code (GEC) and FDA review panel - the closest regulatory comparables to K843636.
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
MEDICAL PRODUCTS FOAM DOUBLE SCRUB #450
K831226 · Ballard Medical Products · May 1983
SURGI-SCRUB V
K822865 · Acme United Corp. · Oct 1982
CURITY SURGICAL SCRUB BRUSH SPONGE
K820086 · The Kendal Co. · Jan 1982