Cleared Special

K013905 - MODIFICATION EZ-1 SYSTEM REPIRATORY SENSORS (FDA 510(k) Clearance)

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

K013905 · Pro-Tech Services, Inc. · Anesthesiology device
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Apr 2002
Decision
147d
Days
Class 2
Risk

K013905 is an FDA 510(k) clearance for the MODIFICATION EZ-1 SYSTEM REPIRATORY SENSORS. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Pro-Tech Services, Inc. (Mukilteo, US). The FDA issued a Cleared decision on April 22, 2002 after a review of 147 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Pro-Tech Services, Inc. devices

Submission Details

510(k) Number K013905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2001
Decision Date April 22, 2002
Days to Decision 147 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
8d slower than avg
Panel avg: 139d · This submission: 147d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MNR Ventilatory Effort Recorder
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
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.