Cleared Traditional

K140880 - DEVILBISS SMARTLINK II SYSTEM

K140880 is an FDA 510(k) clearance for DEVILBISS SMARTLINK II SYSTEM, 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 119-day FDA review.

K140880 · Devilbiss Healthcare, LLC · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
119d
Days
Class 2
Risk

K140880 is an FDA 510(k) clearance for the DEVILBISS SMARTLINK II SYSTEM. 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 August 4, 2014 after a review of 119 days - within the typical 510(k) review window.

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 - K140880

510(k) Number K140880 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2014
Decision Date August 04, 2014
Days to Decision 119 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
21d faster than avg
Panel avg: 140d · This submission: 119d
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 286
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K140880.
Revolution Full Face Mask
K142554 · Respironics, Inc. · Jan 2015
SIMPLE T YOUTH NASAL MASK
K140268 · Respironics, Inc. · Oct 2014
APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SERIES
K141522 · Apex Medical Corp. · Oct 2014
S9 GREENHILLS
K140279 · Resmed, Ltd. · Jul 2014
S9 WANDA VPAP ST
K140159 · Resmed, Ltd. · Jun 2014
AIRSOFT F15
K132901 · Resmed, Ltd. · Jun 2014