Cleared Traditional

K001174 - COSMED QUARK

K001174 is an FDA 510(k) clearance for COSMED QUARK, 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 275-day FDA review.

K001174 · Cosmed Srl · Anesthesiology device
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Jan 2001
Decision
275d
Days
Class 2
Risk

K001174 is an FDA 510(k) clearance for the COSMED QUARK. 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 January 11, 2001 after a review of 275 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 Cosmed Srl devices

FDA 510(k) Submission Details - K001174

510(k) Number K001174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2000
Decision Date January 11, 2001
Days to Decision 275 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
135d slower than avg
Panel avg: 140d · This submission: 275d
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 K001174.
ZAN LUNG-FUNCTION LAB
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AEROSOL PROVOCATION SYSTEM APS PRO, MODEL APS PRO
K001502 · Erich Jaeger GmbH · Jul 2000
OXYCON PRO
K992214 · Erich Jaeger B.V. · Feb 2000
COSMO PLUS WITH NICO, MODEL 8200
K982499 · Novametrix Medical Systems, Inc. · Oct 1998