Cleared Traditional

K854232 - PHARMASEAL SCRUB CARE-SURGICAL SCRUB BR...

K854232 is an FDA 510(k) clearance for PHARMASEAL SCRUB CARE-SURGICAL SCRUB BR..., manufactured by American Pharmaseal Div. Ahsc. The device is a Class 1 General & Plastic Surgery device with product code GEC cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K854232 · American Pharmaseal Div. Ahsc · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1985
Decision
50d
Days
Class 1
Risk

K854232 is an FDA 510(k) clearance for the PHARMASEAL SCRUB CARE-SURGICAL SCRUB BRUSH SPONGES. Classified as Brush, Scrub, Operating-room (product code GEC), Class I - General Controls.

Submitted by American Pharmaseal Div. Ahsc (Valencia, US). The FDA issued a Cleared decision on December 10, 1985 after a review of 50 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 American Pharmaseal Div. Ahsc devices

FDA 510(k) Submission Details - K854232

510(k) Number K854232 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 21, 1985
Decision Date December 10, 1985
Days to Decision 50 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
65d faster than avg
Panel avg: 115d · This submission: 50d
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 K854232.
STERILE SCRUBBY SCRUB BRUSH
K875033 · Medsurg Industries, Inc. · Feb 1988
STERILE SURGICAL SCRUB BRUSH
K874653 · Surgikos, Inc. · Dec 1987
SCRUB MATE DRY STERILE SCRUB BRUSH
K844411 · American Sterilizer Co. · Dec 1984
FOAM CARE ONE STEP PREP
K843636 · Ballard Medical Products · Nov 1984
MEDICAL PRODUCTS FOAM DOUBLE SCRUB #450
K831226 · Ballard Medical Products · May 1983
SURGI-SCRUB V
K822865 · Acme United Corp. · Oct 1982