Cleared Traditional

K161314 - FLEXICARE FL-9000U RESPIRATORY HUMIDIFI...

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

All 110
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K161314.
Salter Labs Bubble Humidifier
K161719 · Salter Labs · Sep 2017
HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010
K163283 · Hamilton Medical AG · Sep 2017
Comfort Flo Humidification System
K162242 · Teleflexmedical, Inc. · Jan 2017
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
HUDSON RCI AQUAPAK HUMIDIFIER ADAPTOR
K141353 · Teleflexmedical, Inc. · Aug 2014