Cleared Traditional

K051288 - VIELLE LUBRICANT

K051288 is an FDA 510(k) clearance for VIELLE LUBRICANT, manufactured by Cst Medical Limited. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K051288 · Cst Medical Limited · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
261d
Days
Class 2
Risk

K051288 is an FDA 510(k) clearance for the VIELLE LUBRICANT. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Cst Medical Limited (Crofton, US). The FDA issued a Cleared decision on February 3, 2006 after a review of 261 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5300 - 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 - K051288

510(k) Number K051288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2005
Decision Date February 03, 2006
Days to Decision 261 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
100d slower than avg
Panel avg: 161d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIS Device Classification - Class 2, Special Controls

Product Code HIS Condom
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5300
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 - HIS Condom

All 396
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K051288.
NAKED
K060797 · Veraxis Int'L, Inc. · Apr 2006
DICK'S FORMALWEAR MALE LATEX CONDOM
K050913 · Dick'S Formalwear, Inc. · Apr 2006
MALE NATURAL RUBBER LATEX CONDOM
K053367 · Innolatex Sdn. Bhd · Feb 2006
DUREX MALE COLORED LATEX CONDOMS WITH SCENTED LUBRICANTS
K052959 · Ssl Americas · Jan 2006
DIVAS DUAL PLEASURE MALE LATEX CONDOM
K051273 · Eagle Twe, Inc. · Aug 2005
MALE NATURAL RUBBER LATEX CONDOM
K050244 · Nrs Global Partners · Apr 2005
K051288 · VIELLE LUBRICANT
Download PDF FDA Summary Cst Medical Limited