Cleared Special

IMASK, MODELS 100, 200 AND 300 (K051559) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K051559 · Vital Signs Colorado, Inc. · Anesthesiology device
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Jul 2005
Decision
25d
Days
Class 2
Risk

K051559 is an FDA 510(k) clearance for the IMASK, MODELS 100, 200 AND 300. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Vital Signs Colorado, Inc. (Englewood, US). The FDA issued a Cleared decision on July 8, 2005 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Vital Signs Colorado, Inc. devices

Submission Details

510(k) Number K051559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2005
Decision Date July 08, 2005
Days to Decision 25 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 140d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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 K051559.
RES TRAXX DATA CENTER
K053205 · Resmed, Ltd. · Feb 2006
M-SERIES PRO CPAP SYTEM
K052110 · Respironics, Inc. · Oct 2005
RES TRAXX DATA CENTER
K051314 · Resmed, Ltd. · Jul 2005
BIPAP AUTO
K050759 · Respironics, Inc. · Jun 2005
RESSCAN
K050775 · Resmed, Ltd. · May 2005
ULTRA MIRAGE II MASK
K050359 · Resmed, Ltd. · Mar 2005