Cleared Traditional

K163300 - ThermoShield HME Filter

K163300 is an FDA 510(k) clearance for ThermoShield HME Filter, 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 120-day FDA review.

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

K163300 is an FDA 510(k) clearance for the ThermoShield HME 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 22, 2017 after a review of 120 days - within the typical 510(k) review window.

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 - K163300

510(k) Number K163300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 129d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - CAH Filter, Bacterial, Breathing-circuit

All 156
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K163300.
Altera Filter and HME/Filter
K192713 · Meditera Tibbi Malzeme San VE Tic AS · Mar 2020
Servo Guard
K182862 · Maquet Critical Care AB · Oct 2019
SafeBreath Filter Mouthpiece
K190022 · MD Diagnostics Limited · Sep 2019
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
VR MEDICAL HEAT AND MOISTURE EXCHANGER AND FILTER
K132709 · Vr Medical · Jul 2014

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.