Cleared Special

K072381 - SOFTPAP CERVICAL CELL COLLECTOR

K072381 is an FDA 510(k) clearance for SOFTPAP CERVICAL CELL COLLECTOR, manufactured by Cytocore, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HHT cleared through the Special 510(k) pathway after a 159-day FDA review.

K072381 · Cytocore, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2008
Decision
159d
Days
Class 2
Risk

K072381 is an FDA 510(k) clearance for the SOFTPAP CERVICAL CELL COLLECTOR. Classified as Spatula, Cervical, Cytological (product code HHT), Class II - Special Controls.

Submitted by Cytocore, Inc. (Chicago, US). The FDA issued a Cleared decision on January 30, 2008 after a review of 159 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K072381

510(k) Number K072381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2007
Decision Date January 30, 2008
Days to Decision 159 days
Submission Type Special
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
2d faster than avg
Panel avg: 161d · This submission: 159d
Pathway characteristics
Modification to existing cleared device.

HHT Device Classification - Class 2, Special Controls

Product Code HHT Spatula, Cervical, Cytological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
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 - HHT Spatula, Cervical, Cytological

All 67
Devices cleared under the same product code (HHT) and FDA review panel - the closest regulatory comparables to K072381.
HISTOBRUSH
K111681 · Puritan Medical Products Company, LLC · Jan 2012
PAPCONE
K083012 · Otto Bock Pur Life Science GmbH · Apr 2009
BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY
K081522 · Bio Nuclear Diagnostics, Inc. · Dec 2008
DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEM
K062433 · Diamics, Inc. · Mar 2007
CERVEX-BRUSH COMBI
K043369 · Rovers Medical Devices B.V. · Feb 2005
SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107
K042527 · Medical Action Industries, Inc. · Nov 2004
K072381 · SOFTPAP CERVICAL CELL COLLECTOR
Download PDF FDA Summary Cytocore, Inc.