Cleared Traditional

K032593 - MERCURY MEDICAL NEGATIVE INSPIRATORY FO...

K032593 is an FDA 510(k) clearance for MERCURY MEDICAL NEGATIVE INSPIRATORY FO..., manufactured by Mercury Medical. The device is a Class 2 Anesthesiology device with product code BXR cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K032593 · Mercury Medical · Anesthesiology device
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Feb 2004
Decision
165d
Days
Class 2
Risk

K032593 is an FDA 510(k) clearance for the MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETER. Classified as Meter, Airway Pressure (inspiratory Force) (product code BXR), Class II - Special Controls.

Submitted by Mercury Medical (Clearwater, US). The FDA issued a Cleared decision on February 3, 2004 after a review of 165 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1780 - 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.

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FDA 510(k) Submission Details - K032593

510(k) Number K032593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2003
Decision Date February 03, 2004
Days to Decision 165 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
25d slower than avg
Panel avg: 140d · This submission: 165d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BXR Device Classification - Class 2, Special Controls

Product Code BXR Meter, Airway Pressure (inspiratory Force)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1780
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.