Cleared Traditional

ThermoShield HME Filter

K163300 · Flexicare Medical Limited. · General Hospital
Mar 2017
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K163300 is an FDA 510(k) clearance for the ThermoShield HME Filter, a Filter, Bacterial, Breathing-circuit (Class II — Special Controls, product code CAH), submitted by Flexicare Medical Limited. (Mountain Ash, GB). The FDA issued a Cleared decision on March 22, 2017, 120 days after receiving the submission on November 22, 2016. This device falls under the General Hospital review panel. Regulated under 21 CFR 868.5260.

Submission Details

510(k) Number K163300 FDA.gov
FDA Decision Cleared SESE
Date Received November 22, 2016
Decision Date March 22, 2017
Days to Decision 120 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code CAH — Filter, Bacterial, Breathing-circuit
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5260

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