Cleared Traditional

MICRO-PAP(TM) KIT (K912325) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K912325 · Micro-Pap Corp. · Obstetrics & Gynecology device
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May 1994
Decision
1074d
Days
Class 2
Risk

K912325 is an FDA 510(k) clearance for the MICRO-PAP(TM) KIT. Classified as Spatula, Cervical, Cytological (product code HHT), Class II - Special Controls.

Submitted by Micro-Pap Corp. (Princeton, US). The FDA issued a Cleared decision on May 2, 1994 after a review of 1074 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Micro-Pap Corp. devices

Submission Details

510(k) Number K912325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received May 24, 1991
Decision Date May 02, 1994
Days to Decision 1074 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
914d slower than avg
Panel avg: 160d · This submission: 1074d
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.