Cleared Traditional

K012277 - PORTEX RING PESSARY PVC-NON STERILE

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

K012277 is an FDA 510(k) clearance for PORTEX RING PESSARY PVC-NON STERILE, manufactured by Sims Portex , Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HHW cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K012277 · Sims Portex , Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K012277

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 161d · This submission: 207d
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 39
Devices cleared under the same product code (HHW) and FDA review panel - the closest regulatory comparables to K012277.
KOLPEXIN SPHERE
K032644 · Adamed , Ltd. · May 2004
MARINA MEDICAL SILICONE PESSARY
K031463 · Marina Medical Instruments, Inc. · Nov 2003
MTI ST#1 SILICONE PESSARY
K020512 · Medical Technology and Innovations, Inc. · May 2002
BIOTEQUE VAGINAL PESSARIES
K013289 · Bioteque America, Inc. · Dec 2001
PELVX GELLHORN VAGINAL PESSARY 603-608
K002329 · Deschutes Medical Products, Inc. · Sep 2000
MENTOR EVACARE VAGINAL PESSARIES
K993308 · Mentor Corp. · Dec 1999
K012277 · PORTEX RING PESSARY PVC-NON STERILE
Download PDF FDA Summary Sims Portex , Ltd.