Cleared Traditional

K161314 - FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE

K161314 is an FDA 510(k) clearance for FLEXICARE FL-9000U RESPIRATORY HUMIDIFI..., manufactured by Flexicare Medical Limited.. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K161314 · Flexicare Medical Limited. · Anesthesiology device
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Jul 2016
Decision
56d
Days
Class 2
Risk

K161314 is an FDA 510(k) clearance for the FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Flexicare Medical Limited. (Mountain Ash, GB). The FDA issued a Cleared decision on July 6, 2016 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5450 - the FDA anesthesiology and respiratory 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Flexicare Medical Limited. devices

FDA 510(k) Submission Details - K161314

510(k) Number K161314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2016
Decision Date July 06, 2016
Days to Decision 56 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
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
84d faster than avg
Panel avg: 140d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

BTT Device Classification - Class 2, Special Controls

Product Code BTT Humidifier, Respiratory Gas, (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5450
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 Anesthesiology devices follow this clearance model.

Regulatory Consultant

Third Party Review Group, LLC
DAVE YUNGVIRT

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 - BTT Humidifier, Respiratory Gas, (direct Patient Interface)

All 172
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K161314.
HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010
K163283 · Hamilton Medical AG · Sep 2017
Comfort Flo Humidification System
K162242 · Teleflexmedical, Inc. · Jan 2017
AirLife Autofill Humidification Chamber
K160764 · Carefusion 2200, Inc. · Aug 2016
HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010
K152029 · Hamilton Medical AG · May 2016
MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit
K143646 · Fisher &Paykel Healthcare , Ltd. · Mar 2015
HUMICARE D900
K133766 · Gruendler GmbH · Nov 2014