Cleared Traditional

PORTEX RING PESSARY PVC-NON STERILE (K012277) - FDA 510(k) Clearance

Also marketed or referenced as:
PORTEX RING PESSARY POLYTHENE- NON STERILE

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K012277 · Sims Portex , Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
207d
Days
Class 2
Risk

K012277 is an FDA 510(k) clearance for the PORTEX RING PESSARY PVC-NON STERILE. Classified as Pessary, Vaginal (product code HHW), Class II - Special Controls.

Submitted by Sims Portex , Ltd. (Hythe, Kent, GB). The FDA issued a Cleared decision on February 11, 2002 after a review of 207 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 Sims Portex , Ltd. devices

Submission Details

510(k) Number K012277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2001
Decision Date February 11, 2002
Days to Decision 207 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
47d slower than avg
Panel avg: 160d · This submission: 207d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 40
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