Cleared Traditional

SafeBreath Filter Mouthpiece

K190022 · MD Diagnostics Limited · General Hospital

Sep 2019

Decision

264d

Days

Class 2

Risk

About This 510(k) Submission

K190022 is an FDA 510(k) clearance for the SafeBreath Filter Mouthpiece, a Filter, Bacterial, Breathing-circuit (Class II — Special Controls, product code CAH), submitted by MD Diagnostics Limited (Maidstone, GB). The FDA issued a Cleared decision on September 25, 2019, 264 days after receiving the submission on January 4, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 868.5260.

Submission Details

510(k) Number	K190022 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 04, 2019
Decision Date	September 25, 2019
Days to Decision	264 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF