Cleared Traditional

K993641 - METALYZER, MODEL 2

Also marketed or referenced as:
METALYZER, MODEL 3

K993641 is an FDA 510(k) clearance for METALYZER, manufactured by Cortex Biophysik GmbH. The device is a Class 2 Anesthesiology device with product code BTY cleared through the Traditional 510(k) pathway after a 413-day FDA review.

K993641 · Cortex Biophysik GmbH · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2000
Decision
413d
Days
Class 2
Risk

K993641 is an FDA 510(k) clearance for the METALYZER, MODEL 2. Classified as Calculator, Predicted Values, Pulmonary Function (product code BTY), Class II - Special Controls.

Submitted by Cortex Biophysik GmbH (Appollo Beach, US). The FDA issued a Cleared decision on December 14, 2000 after a review of 413 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1890 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Cortex Biophysik GmbH devices

FDA 510(k) Submission Details - K993641

510(k) Number K993641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1999
Decision Date December 14, 2000
Days to Decision 413 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
273d slower than avg
Panel avg: 140d · This submission: 413d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTY Device Classification - Class 2, Special Controls

Product Code BTY Calculator, Predicted Values, Pulmonary Function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1890
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.

Regulatory Peers - BTY Calculator, Predicted Values, Pulmonary Function

All 23
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