Cleared Traditional

K022311 - RHINOSTREAM RHINOMANOMETER MODULE (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K022311 · Rhino Metrics A/S · Anesthesiology device
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Oct 2002
Decision
79d
Days
Class 2
Risk

K022311 is an FDA 510(k) clearance for the RHINOSTREAM RHINOMANOMETER MODULE. Classified as Rhinoanemometer (measurement Of Nasal Decongestion) (product code BXQ), Class II - Special Controls.

Submitted by Rhino Metrics A/S (Minneapolis, US). The FDA issued a Cleared decision on October 4, 2002 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1800 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K022311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2002
Decision Date October 04, 2002
Days to Decision 79 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
60d faster than avg
Panel avg: 139d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BXQ Rhinoanemometer (measurement Of Nasal Decongestion)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1800
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.