Cleared Traditional

K141893 - VIBRANCE KEGEL DEVICE (VKD)

K141893 is an FDA 510(k) clearance for VIBRANCE KEGEL DEVICE (VKD), manufactured by Bioinfinity (M) Sdn. Bhd.. The device is a Class 2 Gastroenterology & Urology device with product code HIR cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K141893 · Bioinfinity (M) Sdn. Bhd. · Gastroenterology & Urology device
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Dec 2014
Decision
157d
Days
Class 2
Risk

K141893 is an FDA 510(k) clearance for the VIBRANCE KEGEL DEVICE (VKD). Classified as Perineometer (product code HIR), Class II - Special Controls.

Submitted by Bioinfinity (M) Sdn. Bhd. (Austin, US). The FDA issued a Cleared decision on December 18, 2014 after a review of 157 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 884.1425 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bioinfinity (M) Sdn. Bhd. devices

FDA 510(k) Submission Details - K141893

510(k) Number K141893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2014
Decision Date December 18, 2014
Days to Decision 157 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 131d · This submission: 157d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIR Device Classification - Class 2, Special Controls

Product Code HIR Perineometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1425
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 Gastroenterology & Urology devices follow this clearance model.

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All 43
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