Cleared Traditional

K102136 - VESSEL GUARDIAN

K102136 is an FDA 510(k) clearance for VESSEL GUARDIAN, manufactured by Lexion Medical, LLC. The device is a Class 2 Obstetrics & Gynecology device with product code HIF cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K102136 · Lexion Medical, LLC · Obstetrics & Gynecology device
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Sep 2010
Decision
60d
Days
Class 2
Risk

K102136 is an FDA 510(k) clearance for the VESSEL GUARDIAN. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Lexion Medical, LLC (St. Paul, US). The FDA issued a Cleared decision on September 27, 2010 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1730 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lexion Medical, LLC devices

FDA 510(k) Submission Details - K102136

510(k) Number K102136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2010
Decision Date September 27, 2010
Days to Decision 60 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
100d faster than avg
Panel avg: 160d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIF Device Classification - Class 2, Special Controls

Product Code HIF Insufflator, Laparoscopic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1730
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 - HIF Insufflator, Laparoscopic

All 125
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K102136.
VESSEL GUARDIAN
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FLO-ASSISTANT
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