Cleared Traditional

K020512 - MTI ST#1 SILICONE PESSARY

K020512 is an FDA 510(k) clearance for MTI ST#1 SILICONE PESSARY, manufactured by Medical Technology and Innovations, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HHW cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K020512 · Medical Technology and Innovations, Inc. · Obstetrics & Gynecology device
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May 2002
Decision
90d
Days
Class 2
Risk

K020512 is an FDA 510(k) clearance for the MTI ST#1 SILICONE PESSARY. Classified as Pessary, Vaginal (product code HHW), Class II - Special Controls.

Submitted by Medical Technology and Innovations, Inc. (Lee'S Summit, US). The FDA issued a Cleared decision on May 16, 2002 after a review of 90 days - within the typical 510(k) review window.

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 Medical Technology and Innovations, Inc. devices

FDA 510(k) Submission Details - K020512

510(k) Number K020512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2002
Decision Date May 16, 2002
Days to Decision 90 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 160d · This submission: 90d
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 26
Devices cleared under the same product code (HHW) and FDA review panel - the closest regulatory comparables to K020512.
PANPAC INFLATABLE DOCUT PESSARY
K132670 · Panpac Medical Corporation · Jun 2014
TIPI OTC
K131198 · Contipi , Ltd. · Aug 2013
TIPI
K060526 · Contipi , Ltd. · Jun 2006
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