Cleared Traditional

K132670 - PANPAC INFLATABLE DOCUT PESSARY

K132670 is the FDA 510(k) clearance for PANPAC INFLATABLE DOCUT PESSARY by Panpac Medical Corporation. It is a Class 2 Obstetrics & Gynecology device (product code HHW) cleared through the Traditional 510(k) pathway after a 281-day FDA review.

K132670 · Panpac Medical Corporation · Obstetrics & Gynecology device
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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.

View all Panpac Medical Corporation devices

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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
121d slower than avg
Panel avg: 160d · 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.

Regulatory Peers - HHW Pessary, Vaginal

All 15
Devices cleared under the same product code (HHW) and FDA review panel - the closest regulatory comparables to K132670.
ProVate Vaginal Support
K190277 · Contipi Medical , Ltd. · Jul 2019
Revive Reusable Bladder Support
K183468 · Rinovum Subsidiary 2, LLC · Jan 2019
Panpac Flexi Shelf Pessary
K173351 · Panpac Medical Corporation · Oct 2018
MENTOR EVACARE VAGINAL PESSARIES
K993308 · Mentor Corp. · Dec 1999
INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOL
K965040 · Johnson & Johnson Medical, Inc. · Mar 1997
VAGINAL CONTINENCE DEVICE
K930618 · Johnson & Johnson Medical, Inc. · May 1995