Cleared Traditional

K132670 - PANPAC INFLATABLE DOCUT PESSARY (FDA 510(k) Clearance)

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

K132670 · Panpac Medical Corporation · Obstetrics & Gynecology device
Jun 2014
Decision
281d
Days
Class 2
Risk

K132670 is an FDA 510(k) clearance for the PANPAC INFLATABLE DOCUT PESSARY. Classified as Pessary, Vaginal (product code HHW), Class II - Special Controls.

Submitted by Panpac Medical Corporation (Shi-Chih City, Taipei Hsien, TW). The FDA issued a Cleared decision on June 4, 2014 after a review of 281 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.3575 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K132670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2013
Decision Date June 04, 2014
Days to Decision 281 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 158d · This submission: 281d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HHW Pessary, Vaginal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.3575
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.