Cleared Traditional

K243926 - Vivatmo pro-S

K243926 is an FDA 510(k) clearance for Vivatmo pro-S, manufactured by Bosch Healthcare Solutions GmbH. The device is a Class 2 Chemistry device with product code MXA cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K243926 · Bosch Healthcare Solutions GmbH · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2025
Decision
265d
Days
Class 2
Risk

K243926 is an FDA 510(k) clearance for the Vivatmo pro-S. Classified as System, Test, Breath Nitric Oxide (product code MXA), Class II - Special Controls.

Submitted by Bosch Healthcare Solutions GmbH (Waiblingen, DE). The FDA issued a Cleared decision on September 11, 2025 after a review of 265 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3080 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Bosch Healthcare Solutions GmbH devices

FDA 510(k) Submission Details - K243926

510(k) Number K243926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2024
Decision Date September 11, 2025
Days to Decision 265 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
177d slower than avg
Panel avg: 88d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MXA Device Classification - Class 2, Special Controls

Product Code MXA System, Test, Breath Nitric Oxide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3080
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 Chemistry devices follow this clearance model.

Regulatory Peers - MXA System, Test, Breath Nitric Oxide

Devices cleared under the same product code (MXA) and FDA review panel - the closest regulatory comparables to K243926.
Fenom Flo™ FeNO Monitoring System
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K203695 · Bedfont Scientific, Ltd. · Dec 2021
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K182874 · Spirosure, Inc. · Feb 2019