Cleared Traditional

K191909 - HepaShield Bacterial Viral Breathing Sy...

K191909 is an FDA 510(k) clearance for HepaShield Bacterial Viral Breathing Sy..., manufactured by Flexicare Medical Limited.. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 250-day FDA review.

K191909 · Flexicare Medical Limited. · General Hospital
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Mar 2020
Decision
250d
Days
Class 2
Risk

K191909 is an FDA 510(k) clearance for the HepaShield Bacterial Viral Breathing System Filter. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Flexicare Medical Limited. (Mountain Ash, GB). The FDA issued a Cleared decision on March 23, 2020 after a review of 250 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 Flexicare Medical Limited. devices

FDA 510(k) Submission Details - K191909

510(k) Number K191909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2019
Decision Date March 23, 2020
Days to Decision 250 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
121d slower than avg
Panel avg: 129d · This submission: 250d
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 79
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K191909.
GGM Breathing Circuit Bacterial Filter
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