Cleared Traditional

K090456 - INSUFLOW

K090456 is an FDA 510(k) clearance for INSUFLOW, 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 184-day FDA review.

K090456 · Lexion Medical, LLC · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
184d
Days
Class 2
Risk

K090456 is an FDA 510(k) clearance for the INSUFLOW. 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 August 26, 2009 after a review of 184 days - an extended review 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: 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 Lexion Medical, LLC devices

FDA 510(k) Submission Details - K090456

510(k) Number K090456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2009
Decision Date August 26, 2009
Days to Decision 184 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
24d slower than avg
Panel avg: 160d · This submission: 184d
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 K090456.
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SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR
K070783 · Sopro · Dec 2007
FLO-ASSISTANT
K041560 · Northgate Technologies, Inc. · Sep 2004