Cleared Traditional

K001631 - CORTEX METAMAX

K001631 is an FDA 510(k) clearance for CORTEX METAMAX, manufactured by Cortex Biophysik GmbH. The device is a Class 2 Anesthesiology device with product code BZC cleared through the Traditional 510(k) pathway after a 272-day FDA review.

K001631 · Cortex Biophysik GmbH · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
272d
Days
Class 2
Risk

K001631 is an FDA 510(k) clearance for the CORTEX METAMAX. Classified as Calculator, Pulmonary Function Data (product code BZC), Class II - Special Controls.

Submitted by Cortex Biophysik GmbH (Appollo Beach, US). The FDA issued a Cleared decision on February 22, 2001 after a review of 272 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1880 - 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 Cortex Biophysik GmbH devices

FDA 510(k) Submission Details - K001631

510(k) Number K001631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2000
Decision Date February 22, 2001
Days to Decision 272 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
132d slower than avg
Panel avg: 140d · This submission: 272d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZC Device Classification - Class 2, Special Controls

Product Code BZC Calculator, Pulmonary Function Data
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1880
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 - BZC Calculator, Pulmonary Function Data

All 35
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