Cleared Traditional

K143677 - DeVilbiss Intellipap2/DeVilbiss BLUE

K143677 is an FDA 510(k) clearance for DeVilbiss Intellipap2/DeVilbiss BLUE, manufactured by Devilbiss Healthcare, LLC. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K143677 · Devilbiss Healthcare, LLC · Anesthesiology device
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Sep 2015
Decision
268d
Days
Class 2
Risk

K143677 is an FDA 510(k) clearance for the DeVilbiss Intellipap2/DeVilbiss BLUE. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Devilbiss Healthcare, LLC (Somerset, US). The FDA issued a Cleared decision on September 18, 2015 after a review of 268 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 Devilbiss Healthcare, LLC devices

FDA 510(k) Submission Details - K143677

510(k) Number K143677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 2014
Decision Date September 18, 2015
Days to Decision 268 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
128d slower than avg
Panel avg: 140d · This submission: 268d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Anesthesiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01797705 Completed Interventional Industry-sponsored

Revised Algorithm for Next Generation DeVilbiss Healthcare AutoAdjust Continuous Positive Airway Pressure (CPAP)

Revised Algorithm for Next Generation DeVilbiss AutoAdjust CPAP

33
Patients (actual)
1
Site
Diagnostic
Purpose
Open label
Masking
Condition studied Obstructive Sleep Apnea
Study design Single group
Eligibility All sexes · 21 Years+ · Healthy volunteers accepted
Sponsor DeVilbiss Healthcare LLC (industry)
Started 2013-01-01 → Primary completion 2014-05-01
Primary outcome
% Agreement Between Reviewer and Machine Pressure Settings During Sleep Study
View full study on ClinicalTrials.gov

Regulatory Peers - BZD Ventilator, Non-continuous (respirator)

All 443
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K143677.
SleepWeaver Advance Pediatric Nasal CPAP Mask
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Sapphire
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AF541 EE Full Face Mask
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Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series
K150111 · Apex Medical Corp. · Sep 2015
Skynector CPAP Mask
K150685 · Sky Wise Medical Instrument (Shen Zhen) Co., Ltd. · Aug 2015