Cleared Traditional

K120146 - QUARK SERIES

K120146 is an FDA 510(k) clearance for QUARK SERIES, manufactured by Cosmed Srl. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 328-day FDA review.

K120146 · Cosmed Srl · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2012
Decision
328d
Days
Class 2
Risk

K120146 is an FDA 510(k) clearance for the QUARK SERIES. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Cosmed Srl (West Caldwell, US). The FDA issued a Cleared decision on December 11, 2012 after a review of 328 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - 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 - K120146

510(k) Number K120146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2012
Decision Date December 11, 2012
Days to Decision 328 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
188d slower than avg
Panel avg: 140d · This submission: 328d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBK Device Classification - Class 2, Special Controls

Product Code CBK Ventilator, Continuous, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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 - CBK Ventilator, Continuous, Facility Use

All 250
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K120146.
HAMILTON-MR1
K122438 · Hamilton Medical AG · Nov 2013
HAMILTON-G5
K131774 · Hamilton Medical AG · Oct 2013
HAMILTON-C3
K123637 · Hamilton Medical AG · Dec 2012
HAMILTON-C2
K121225 · Hamilton Medical AG · Nov 2012
PERFORMAX PEDIATRIC SE TOTAL FACE MASK
K120639 · Respironics, Inc. · Jul 2012
HAMILTON-C1
K120574 · Hamilton Medical AG · May 2012