Cleared Traditional

BESTFIT2 NASAL MASK (K130663) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K130663 · Curative Medical, Inc. · Anesthesiology device
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Sep 2013
Decision
199d
Days
Class 2
Risk

K130663 is an FDA 510(k) clearance for the BESTFIT2 NASAL MASK. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Curative Medical, Inc. (Fulshear, US). The FDA issued a Cleared decision on September 27, 2013 after a review of 199 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Curative Medical, Inc. devices

Submission Details

510(k) Number K130663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2013
Decision Date September 27, 2013
Days to Decision 199 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 140d · This submission: 199d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZD Ventilator, Non-continuous (respirator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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 - BZD Ventilator, Non-continuous (respirator)

All 208
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K130663.
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K130077 · Respironics, Inc. · May 2013
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K123789 · Resmed, Ltd. · Mar 2013
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K122847 · Respironics, Inc. · Mar 2013