Cleared Traditional

K862242 - PAP SMEAR KIT

K862242 is the FDA 510(k) clearance for PAP SMEAR KIT by Quali-Med, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HHT) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K862242 · Quali-Med, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1986
Decision
14d
Days
Class 2
Risk

K862242 is an FDA 510(k) clearance for the PAP SMEAR KIT. Classified as Spatula, Cervical, Cytological (product code HHT), Class II - Special Controls.

Submitted by Quali-Med, Inc. (Sugar Land, US). The FDA issued a Cleared decision on June 26, 1986 after a review of 14 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.

View all Quali-Med, Inc. devices

Submission Details

510(k) Number K862242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1986
Decision Date June 26, 1986
Days to Decision 14 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
146d faster than avg
Panel avg: 160d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.