Cleared Traditional

Aluna (K193311) - FDA 510(k) Clearance

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

K193311 · Knox Medical Diagnostics, Inc. · Anesthesiology device
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Mar 2020
Decision
117d
Days
Class 2
Risk

K193311 is an FDA 510(k) clearance for the Aluna. Classified as Meter, Peak Flow, Spirometry (product code BZH), Class II - Special Controls.

Submitted by Knox Medical Diagnostics, Inc. (San Francisco, US). The FDA issued a Cleared decision on March 25, 2020 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1860 - 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 Knox Medical Diagnostics, Inc. devices

Submission Details

510(k) Number K193311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2019
Decision Date March 25, 2020
Days to Decision 117 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 139d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZH Meter, Peak Flow, Spirometry
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1860
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 Consultant

Acknowledge Regulatory Strategies
Pierre Bounaud

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - BZH Meter, Peak Flow, Spirometry

All 79
Devices cleared under the same product code (BZH) and FDA review panel - the closest regulatory comparables to K193311.
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K232588 · Knox Medical Diagnostics · Nov 2024
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K203196 · Shanghai Sonmol Medical Equipment Co., Ltd. · May 2021