Cleared Traditional

K021490 - REEVUE INDIRECT CALORIMETER, MODEL#8100

K021490 is an FDA 510(k) clearance for REEVUE INDIRECT CALORIMETER, manufactured by Korr Medical Technologies, Inc.. The device is a Class 2 Anesthesiology device with product code BZL cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K021490 · Korr Medical Technologies, Inc. · Anesthesiology device
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Jan 2003
Decision
238d
Days
Class 2
Risk

K021490 is an FDA 510(k) clearance for the REEVUE INDIRECT CALORIMETER, MODEL#8100. Classified as Computer, Oxygen-uptake (product code BZL), Class II - Special Controls.

Submitted by Korr Medical Technologies, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on January 2, 2003 after a review of 238 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1730 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Korr Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K021490

510(k) Number K021490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2002
Decision Date January 02, 2003
Days to Decision 238 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d slower than avg
Panel avg: 140d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZL Device Classification - Class 2, Special Controls

Product Code BZL Computer, Oxygen-uptake
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1730
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 Anesthesiology devices follow this clearance model.

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