Cleared Traditional

QUARK SERIES

K120146 · Cosmed Srl · Anesthesiology
Dec 2012
Decision
328d
Days
Class 2
Risk

About This 510(k) Submission

K120146 is an FDA 510(k) clearance for the QUARK SERIES, a Ventilator, Continuous, Facility Use (Class II — Special Controls, product code CBK), submitted by Cosmed Srl (West Caldwell, US). The FDA issued a Cleared decision on December 11, 2012, 328 days after receiving the submission on January 18, 2012. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K120146 FDA.gov
FDA Decision Cleared 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

Device Classification

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

Similar Devices — CBK Ventilator, Continuous, Facility Use

All 502
VPAP Pediatric Face Mask
K251888 · Hsiner Co., Ltd. · Mar 2026
Vivo 45 LS
K232365 · Oconnell Regulatory Consultants, Inc. · Dec 2025
F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits ? Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits ? Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits ? Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full
K252173 · Fisher &Paykel Healthcare , Ltd. · Sep 2025
SV600, SV800 Ventilator
K243767 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Aug 2025
AVEA disposable expiratory filter/water trap (11790)
K251133 · Telesair, Inc. · May 2025
AF531 Oro-Nasal SE Face Mask
K243394 · Respironics, Inc. · Dec 2024