Cleared Traditional

K062155 - DIGITAL MXR-D FLOWMETER

K062155 is an FDA 510(k) clearance for DIGITAL MXR-D FLOWMETER, manufactured by Porter Instrument Co., Inc.. The device is a Class 2 Anesthesiology device with product code BSZ cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K062155 · Porter Instrument Co., Inc. · Anesthesiology device
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Nov 2006
Decision
104d
Days
Class 2
Risk

K062155 is an FDA 510(k) clearance for the DIGITAL MXR-D FLOWMETER. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Porter Instrument Co., Inc. (North Attleboro, US). The FDA issued a Cleared decision on November 9, 2006 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5160 - 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 Porter Instrument Co., Inc. devices

FDA 510(k) Submission Details - K062155

510(k) Number K062155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2006
Decision Date November 09, 2006
Days to Decision 104 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
36d faster than avg
Panel avg: 140d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSZ Device Classification - Class 2, Special Controls

Product Code BSZ Gas-machine, Anesthesia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5160
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 - BSZ Gas-machine, Anesthesia

All 115
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