Cleared Traditional

K093510 - LUMENVU CATHETER GUIDANCE SYSTEM

K093510 is an FDA 510(k) clearance for LUMENVU CATHETER GUIDANCE SYSTEM, manufactured by Sonosite,Inc.. The device is a Class 2 General Hospital device with product code OMF cleared through the Traditional 510(k) pathway after a 284-day FDA review.

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

FDA 510(k) Submission Details - K093510

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
155d slower than avg
Panel avg: 129d · This submission: 284d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OMF Device Classification - Class 2, Special Controls

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.