Cleared Traditional

K983181 - CYTOPREP

K983181 is an FDA 510(k) clearance for CYTOPREP, manufactured by Cytoprep Inc. Est.. The device is a Class 2 Obstetrics & Gynecology device with product code HHI cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K983181 · Cytoprep Inc. Est. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
66d
Days
Class 2
Risk

K983181 is an FDA 510(k) clearance for the CYTOPREP. Classified as System, Abortion, Vacuum (product code HHI), Class II - Special Controls.

Submitted by Cytoprep Inc. Est. (Eschen, LI). The FDA issued a Cleared decision on November 16, 1998 after a review of 66 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 Cytoprep Inc. Est. devices

FDA 510(k) Submission Details - K983181

510(k) Number K983181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1998
Decision Date November 16, 1998
Days to Decision 66 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 160d · This submission: 66d
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

Devices cleared under the same product code (HHI) and FDA review panel - the closest regulatory comparables to K983181.
Berkeley VC-10 Vacuum Curettage System
K171440 · Gyrus Acmi · Sep 2017
BERKELEY V-10 VACUUM CURETTAGE SYSTEM
K030935 · Acmi Corporation · Jun 2003
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