Cleared Traditional

K132313 - PESSARY

K132313 is an FDA 510(k) clearance for PESSARY, manufactured by Eis Corporation. The device is a Class 2 Obstetrics & Gynecology device with product code HHW cleared through the Traditional 510(k) pathway after a 498-day FDA review.

K132313 · Eis Corporation · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2014
Decision
498d
Days
Class 2
Risk

K132313 is an FDA 510(k) clearance for the PESSARY. Classified as Pessary, Vaginal (product code HHW), Class II - Special Controls.

Submitted by Eis Corporation (Gangnam-Gu, KR). The FDA issued a Cleared decision on December 5, 2014 after a review of 498 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.3575 - 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: 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.

FDA 510(k) Submission Details - K132313

510(k) Number K132313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2013
Decision Date December 05, 2014
Days to Decision 498 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
337d slower than avg
Panel avg: 161d · This submission: 498d
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 38
Devices cleared under the same product code (HHW) and FDA review panel - the closest regulatory comparables to K132313.
Panpac Flexi Shelf Pessary
K173351 · Panpac Medical Corporation · Oct 2018
Panpac Disposable Pessary Fitting Set
K153422 · Panpac Medical Corporation · Jul 2016
Always/Tampax bladder supports
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PANPAC INFLATABLE DOCUT PESSARY
K132670 · Panpac Medical Corporation · Jun 2014
TIPI OTC
K131198 · Contipi , Ltd. · Aug 2013
PANPAC VAGINAL PESSARY
K092981 · Panpac Medical Corporation · Jul 2010
K132313 · PESSARY
Download PDF FDA Summary Eis Corporation