Cleared Traditional

K132670 - PANPAC INFLATABLE DOCUT PESSARY

K132670 is an FDA 510(k) clearance for PANPAC INFLATABLE DOCUT PESSARY, manufactured by Panpac Medical Corporation. The device is a Class 2 Obstetrics & Gynecology device with 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

FDA 510(k) Submission Details - K132670

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.

HHW Device Classification - Class 2, Special Controls

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 24
Devices cleared under the same product code (HHW) and FDA review panel - the closest regulatory comparables to K132670.
Panpac Disposable Pessary Fitting Set
K153422 · Panpac Medical Corporation · Jul 2016
Always/Tampax bladder supports
K151413 · Procter & Gamble · Dec 2015
PESSARY
K132313 · Eis Corporation · Dec 2014
TIPI OTC
K131198 · Contipi , Ltd. · Aug 2013
MENTOR EVACARE VAGINAL PESSARIES
K993308 · Mentor Corp. · Dec 1999
PELVX INCONTINENCE DISH, MODEL 301-306
K990593 · Deschutes Medical Products, Inc. · May 1999