Cleared Traditional

K190022 - SafeBreath Filter Mouthpiece

K190022 is the FDA 510(k) clearance for SafeBreath Filter Mouthpiece by MD Diagnostics Limited. It is a Class 2 General Hospital device (product code CAH) cleared through the Traditional 510(k) pathway after a 264-day FDA review.

K190022 · MD Diagnostics Limited · General Hospital
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Sep 2019
Decision
264d
Days
Class 2
Risk

K190022 is an FDA 510(k) clearance for the SafeBreath Filter Mouthpiece. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by MD Diagnostics Limited (Maidstone, GB). The FDA issued a Cleared decision on September 25, 2019 after a review of 264 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 868.5260 - the FDA general hospital 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all MD Diagnostics Limited devices

Submission Details

510(k) Number K190022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
135d slower than avg
Panel avg: 129d · This submission: 264d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CAH Filter, Bacterial, Breathing-circuit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5260
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 General Hospital devices follow this clearance model.

Regulatory Peers - CAH Filter, Bacterial, Breathing-circuit

All 70
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K190022.
HepaShield Bacterial Viral Breathing System Filter
K191909 · Flexicare Medical Limited. · Mar 2020
Altera Filter and HME/Filter
K192713 · Meditera Tibbi Malzeme San VE Tic AS · Mar 2020
Servo Guard
K182862 · Maquet Critical Care AB · Oct 2019
RT016 INSPIRATORY FILTER
K133666 · Fisher &Paykel Healthcare , Ltd. · Feb 2014
HUMID-VENT HEPA
K112958 · Teleflex Medical · Sep 2012
RT019 INSPIRATORY/EXPIRATORY FILTER
K050927 · Fisher &Paykel Healthcare , Ltd. · Aug 2005