Cleared Traditional

K092981 - PANPAC VAGINAL PESSARY

K092981 is an FDA 510(k) clearance for PANPAC VAGINAL 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 297-day FDA review.

K092981 · Panpac Medical Corporation · Obstetrics & Gynecology device
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Jul 2010
Decision
297d
Days
Class 2
Risk

K092981 is an FDA 510(k) clearance for the PANPAC VAGINAL 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 July 22, 2010 after a review of 297 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 - K092981

510(k) Number K092981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2009
Decision Date July 22, 2010
Days to Decision 297 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
137d slower than avg
Panel avg: 160d · This submission: 297d
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 25
Devices cleared under the same product code (HHW) and FDA review panel - the closest regulatory comparables to K092981.
PESSARY
K132313 · Eis Corporation · Dec 2014
PANPAC INFLATABLE DOCUT PESSARY
K132670 · Panpac Medical Corporation · Jun 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
PELVX RING, PELVX RING WITH SUPPORT
K974115 · Deschutes Medical Products, Inc. · Apr 1998