Cleared Traditional

K143700 - CPAP Cannulaide

K143700 is an FDA 510(k) clearance for CPAP Cannulaide, manufactured by Salter Labs. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K143700 · Salter Labs · Anesthesiology device
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Aug 2015
Decision
224d
Days
Class 2
Risk

K143700 is an FDA 510(k) clearance for the CPAP Cannulaide. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Salter Labs (Carlsbad, US). The FDA issued a Cleared decision on August 5, 2015 after a review of 224 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 Salter Labs devices

FDA 510(k) Submission Details - K143700

510(k) Number K143700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 2014
Decision Date August 05, 2015
Days to Decision 224 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d slower than avg
Panel avg: 140d · This submission: 224d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZD Device Classification - Class 2, Special Controls

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 285
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K143700.
Sapphire
K152356 · Respironics, Inc. · Jan 2016
AF541 EE Full Face Mask
K150639 · Respironics, Inc. · Sep 2015
Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series
K150111 · Apex Medical Corp. · Sep 2015
Darlinghurst Vented, Darlinghurst NV-AAV
K143603 · Resmed, Ltd. · May 2015
TI NASAL MASK
K140980 · Respironics, Inc. · Feb 2015
Revolution Full Face Mask
K142554 · Respironics, Inc. · Jan 2015