Cleared Traditional

K014262 - COSMED QUARK C12/QUARK T12

K014262 is an FDA 510(k) clearance for COSMED QUARK C12/QUARK T12, manufactured by Cosmed Srl. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K014262 · Cosmed Srl · Cardiovascular device
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Mar 2002
Decision
89d
Days
Class 2
Risk

K014262 is an FDA 510(k) clearance for the COSMED QUARK C12/QUARK T12. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Cosmed Srl (West Cadwell, US). The FDA issued a Cleared decision on March 26, 2002 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cosmed Srl devices

FDA 510(k) Submission Details - K014262

510(k) Number K014262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2001
Decision Date March 26, 2002
Days to Decision 89 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 125d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DPS Electrocardiograph

All 466
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K014262.
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K012686 · Caird Technology · Dec 2001