Cleared Traditional

K974117 - PELVX DONUT

K974117 is an FDA 510(k) clearance for PELVX DONUT, manufactured by Deschutes Medical Products, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HHW cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K974117 · Deschutes Medical Products, Inc. · Obstetrics & Gynecology device
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Apr 1998
Decision
178d
Days
Class 2
Risk

K974117 is an FDA 510(k) clearance for the PELVX DONUT, PELVX CUBE. Classified as Pessary, Vaginal (product code HHW), Class II - Special Controls.

Submitted by Deschutes Medical Products, Inc. (Bend, US). The FDA issued a Cleared decision on April 27, 1998 after a review of 178 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 Deschutes Medical Products, Inc. devices

FDA 510(k) Submission Details - K974117

510(k) Number K974117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1997
Decision Date April 27, 1998
Days to Decision 178 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
18d slower than avg
Panel avg: 160d · This submission: 178d
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 16
Devices cleared under the same product code (HHW) and FDA review panel - the closest regulatory comparables to K974117.
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