Cleared Traditional

K013289 - BIOTEQUE VAGINAL PESSARIES

K013289 is an FDA 510(k) clearance for BIOTEQUE VAGINAL PESSARIES, manufactured by Bioteque America, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HHW cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K013289 · Bioteque America, Inc. · Obstetrics & Gynecology device
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Dec 2001
Decision
86d
Days
Class 2
Risk

K013289 is an FDA 510(k) clearance for the BIOTEQUE VAGINAL PESSARIES. Classified as Pessary, Vaginal (product code HHW), Class II - Special Controls.

Submitted by Bioteque America, Inc. (Langhorne, US). The FDA issued a Cleared decision on December 27, 2001 after a review of 86 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bioteque America, Inc. devices

FDA 510(k) Submission Details - K013289

510(k) Number K013289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2001
Decision Date December 27, 2001
Days to Decision 86 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
74d faster than avg
Panel avg: 160d · This submission: 86d
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 21
Devices cleared under the same product code (HHW) and FDA review panel - the closest regulatory comparables to K013289.
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