Cleared Traditional

K093510 - LUMENVU CATHETER GUIDANCE SYSTEM (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K093510 · Sonosite,Inc. · General Hospital
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Aug 2010
Decision
284d
Days
Class 2
Risk

K093510 is an FDA 510(k) clearance for the LUMENVU CATHETER GUIDANCE SYSTEM. Classified as Percutaneous, Implanted, Long-term Intravascular Catheter Accessory For Catheter Position (product code OMF), Class II - Special Controls.

Submitted by Sonosite,Inc. (Philedelphia, US). The FDA issued a Cleared decision on August 23, 2010 after a review of 284 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5970 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Sonosite,Inc. devices

Submission Details

510(k) Number K093510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2009
Decision Date August 23, 2010
Days to Decision 284 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
156d slower than avg
Panel avg: 128d · This submission: 284d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OMF Percutaneous, Implanted, Long-term Intravascular Catheter Accessory For Catheter Position
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5970
Definition When Used In Connection With A Locator Instrument Is Designed To Aid In The Placement Of Central Venous Catheters By Providing Real-time Information As To The Position Of The Catheter Inside The Body During The Catheter Insertion Procedure.
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 General Hospital devices follow this clearance model.