Cleared Traditional

K870398 - PAP-PAK CYTOBRUSH KIT

K870398 is an FDA 510(k) clearance for PAP-PAK CYTOBRUSH KIT, manufactured by Medical Packaging Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HHT cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K870398 · Medical Packaging Corp. · Obstetrics & Gynecology device
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Feb 1987
Decision
23d
Days
Class 2
Risk

K870398 is an FDA 510(k) clearance for the PAP-PAK CYTOBRUSH KIT. Classified as Spatula, Cervical, Cytological (product code HHT), Class II - Special Controls.

Submitted by Medical Packaging Corp. (Panorama City, US). The FDA issued a Cleared decision on February 25, 1987 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - 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.

FDA 510(k) Submission Details - K870398

510(k) Number K870398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1987
Decision Date February 25, 1987
Days to Decision 23 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
138d faster than avg
Panel avg: 161d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 72
Devices cleared under the same product code (HHT) and FDA review panel - the closest regulatory comparables to K870398.
HISTOBRUSH
K874604 · Spectrum Co. · Jan 1988
ORTHO* SPECIMEN COLLECTION CYTOBRUSH
K871552 · Ortho Diagnostic Systems, Inc. · Jun 1987
CYCLO-BRUSH
K870782 · Medline Industries, Inc. · May 1987
CYTOLOGY BRUSHES
K864323 · Medical Packaging Corp. · Jan 1987
CERVICAL SCRAPERS
K863145 · Surgipath Medical Industries, Inc. · Aug 1986
CHLAMYDIA KIT, STD KIT
K862322 · Intl. Cytobrush, Inc. · Jul 1986
K870398 · PAP-PAK CYTOBRUSH KIT
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