Cleared Traditional

K083121 - NEO MAPCATH SENSOR STYLET (FDA 510(k) Clearance)

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

K083121 · Corpak Medsystems · General Hospital
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Feb 2009
Decision
112d
Days
Class 2
Risk

K083121 is an FDA 510(k) clearance for the NEO MAPCATH SENSOR STYLET. Classified as Percutaneous, Implanted, Long-term Intravascular Catheter Accessory For Catheter Position (product code OMF), Class II - Special Controls.

Submitted by Corpak Medsystems (Wheeling, US). The FDA issued a Cleared decision on February 11, 2009 after a review of 112 days - within the typical 510(k) review window.

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.

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Submission Details

510(k) Number K083121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2008
Decision Date February 11, 2009
Days to Decision 112 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 129d · This submission: 112d
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.