Cleared Traditional

K904160 - CYTOSMEAR BRUSH

K904160 is an FDA 510(k) clearance for CYTOSMEAR BRUSH, manufactured by Brooke Intl.. The device is a Class 2 Obstetrics & Gynecology device with product code HHI cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K904160 · Brooke Intl. · Obstetrics & Gynecology device
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Nov 1990
Decision
52d
Days
Class 2
Risk

K904160 is an FDA 510(k) clearance for the CYTOSMEAR BRUSH. Classified as System, Abortion, Vacuum (product code HHI), Class II - Special Controls.

Submitted by Brooke Intl. (Pasadena, US). The FDA issued a Cleared decision on November 2, 1990 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5070 - the FDA obstetrics and gynecology 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 Brooke Intl. devices

FDA 510(k) Submission Details - K904160

510(k) Number K904160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1990
Decision Date November 02, 1990
Days to Decision 52 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 160d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HHI Device Classification - Class 2, Special Controls

Product Code HHI System, Abortion, Vacuum
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5070
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HHI System, Abortion, Vacuum

All 7
Devices cleared under the same product code (HHI) and FDA review panel - the closest regulatory comparables to K904160.
BERKELEY V-10 VACUUM CURETTAGE SYSTEM
K030935 · Acmi Corporation · Jun 2003
CYTOPREP
K983181 · Cytoprep Inc. Est. · Nov 1998
MEDI VAC SPECIMEN COLLECTOR AND TRANSPORTER
K931205 · Baxter Healthcare Corp · Mar 1994
SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS
K880734 · Personal Products Co. · Apr 1988
GYNASPYR VACUUM CURETTAGE UNIT
K850312 · Roseburg SA · Feb 1985
UTERINE VACUM ASPIRATING CURRETTE
K802360 · American Hospital Supply Corp. · Oct 1980