Cleared Traditional

K011238 - RODA (REAL TIME OXYGEN DYNAMICS ANALYSIS) MONITORING SYSTEM

K011238 is an FDA 510(k) clearance for RODA (REAL TIME OXYGEN DYNAMICS ANALYSI..., manufactured by Metracor Technologies, Inc.. The device is a Class 2 General Hospital device with product code LZF cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K011238 · Metracor Technologies, Inc. · General Hospital
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Jan 2002
Decision
260d
Days
Class 2
Risk

K011238 is an FDA 510(k) clearance for the RODA (REAL TIME OXYGEN DYNAMICS ANALYSIS) MONITORING SYSTEM. Classified as Pump, Infusion, Analytical Sampling (product code LZF), Class II - Special Controls.

Submitted by Metracor Technologies, Inc. (San Diego, US). The FDA issued a Cleared decision on January 8, 2002 after a review of 260 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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 Metracor Technologies, Inc. devices

FDA 510(k) Submission Details - K011238

510(k) Number K011238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2001
Decision Date January 08, 2002
Days to Decision 260 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
131d slower than avg
Panel avg: 129d · This submission: 260d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LZF Device Classification - Class 2, Special Controls

Product Code LZF Pump, Infusion, Analytical Sampling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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.