Cleared Traditional

K920747 - PESSARY FLEXIBLE SILICONE DONUT RING

K920747 is an FDA 510(k) clearance for PESSARY FLEXIBLE SILICONE DONUT RING, 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 922-day FDA review.

K920747 · Bioteque America, Inc. · Obstetrics & Gynecology device
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Aug 1994
Decision
922d
Days
Class 2
Risk

K920747 is an FDA 510(k) clearance for the PESSARY FLEXIBLE SILICONE DONUT RING. 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 August 29, 1994 after a review of 922 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.

View all Bioteque America, Inc. devices

FDA 510(k) Submission Details - K920747

510(k) Number K920747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1992
Decision Date August 29, 1994
Days to Decision 922 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
762d slower than avg
Panel avg: 160d · This submission: 922d
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 K920747.
INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOL
K965040 · Johnson & Johnson Medical, Inc. · Mar 1997
VAGINAL CONTINENCE DEVICE
K930618 · Johnson & Johnson Medical, Inc. · May 1995
BLADDER NECK SUPPORT PROTHESIS FITTING KIT
K933654 · Johnson & Johnson Medical, Inc. · May 1995
FEMALE CONTINENCE DEVICE
K883721 · Cook Ob/Gyn · Oct 1988
SILASTIC BRAND INTRAVAGINAL TARSETTE
K771548 · Dow Corning Corp. Healthcare Industries Materials · Nov 1977