Cleared Traditional

K070714 - MEDISIZE GOLD HEATER AND BOOSTER

K070714 is an FDA 510(k) clearance for MEDISIZE GOLD HEATER AND BOOSTER, manufactured by Medisize BV. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K070714 · Medisize BV · Anesthesiology device
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Apr 2007
Decision
47d
Days
Class 2
Risk

K070714 is an FDA 510(k) clearance for the MEDISIZE GOLD HEATER AND BOOSTER. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Medisize BV (Hillegom, NL). The FDA issued a Cleared decision on April 30, 2007 after a review of 47 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 Medisize BV devices

FDA 510(k) Submission Details - K070714

510(k) Number K070714 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2007
Decision Date April 30, 2007
Days to Decision 47 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 140d · This submission: 47d
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 124
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K070714.
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