Cleared Traditional

K190022 - SafeBreath Filter Mouthpiece

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

K190022 · MD Diagnostics Limited · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K190022

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.

CAH Device Classification - Class 2, Special Controls

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 141
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
ThermoShield HME Filter
K163300 · Flexicare Medical Limited. · Mar 2017
Breathing circuit bacterial/viral filter
K151498 · Zhejiang Haisheng Medical Device Co., Ltd. · Dec 2015
INTER-THERM PEDIATRIC HMEF, INTERN-THERM MINI PEDIATRIC ANGLED HMEF
K141087 · Intersurgical Incorporated · Feb 2015