Cleared Traditional

K963373 - COSMED K4

K963373 is an FDA 510(k) clearance for COSMED K4, manufactured by Cosmed Srl. The device is a Class 2 Anesthesiology device with product code BZC cleared through the Traditional 510(k) pathway after a 379-day FDA review.

K963373 · Cosmed Srl · Anesthesiology device
Download Printable Device Report (PDF)
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Sep 1997
Decision
379d
Days
Class 2
Risk

K963373 is an FDA 510(k) clearance for the COSMED K4. Classified as Calculator, Pulmonary Function Data (product code BZC), Class II - Special Controls.

Submitted by Cosmed Srl (West Cadwell, US). The FDA issued a Cleared decision on September 10, 1997 after a review of 379 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Cosmed Srl devices

FDA 510(k) Submission Details - K963373

510(k) Number K963373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1996
Decision Date September 10, 1997
Days to Decision 379 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
239d slower than avg
Panel avg: 140d · This submission: 379d
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 48
Devices cleared under the same product code (BZC) and FDA review panel - the closest regulatory comparables to K963373.
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