Cleared Traditional

K052615 - MEDISIZE GOLD

K052615 is an FDA 510(k) clearance for MEDISIZE GOLD, 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 77-day FDA review.

K052615 · Medisize BV · Anesthesiology device
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Dec 2005
Decision
77d
Days
Class 2
Risk

K052615 is an FDA 510(k) clearance for the MEDISIZE GOLD. 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 December 9, 2005 after a review of 77 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.

FDA 510(k) Submission Details - K052615

510(k) Number K052615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2005
Decision Date December 09, 2005
Days to Decision 77 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 140d · This submission: 77d
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

Kema Quality B.V.
J.A. VAN VUGT

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 179
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