Cleared Traditional

K032644 - KOLPEXIN SPHERE

K032644 is an FDA 510(k) clearance for KOLPEXIN SPHERE, manufactured by Adamed , Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HHW cleared through the Traditional 510(k) pathway after a 275-day FDA review.

K032644 · Adamed , Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
275d
Days
Class 2
Risk

K032644 is an FDA 510(k) clearance for the KOLPEXIN SPHERE. Classified as Pessary, Vaginal (product code HHW), Class II - Special Controls.

Submitted by Adamed , Ltd. (Plano, US). The FDA issued a Cleared decision on May 28, 2004 after a review of 275 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 Adamed , Ltd. devices

FDA 510(k) Submission Details - K032644

510(k) Number K032644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2003
Decision Date May 28, 2004
Days to Decision 275 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
115d slower than avg
Panel avg: 160d · This submission: 275d
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 K032644.
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K974115 · Deschutes Medical Products, Inc. · Apr 1998