Cleared Traditional

K233775 - Vivatmo pro

K233775 is an FDA 510(k) clearance for Vivatmo pro, 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 90-day FDA review.

K233775 · Bosch Healthcare Solutions GmbH · Chemistry device
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Optimized for regulatory review, auditing and printing
Feb 2024
Decision
90d
Days
Class 2
Risk

K233775 is an FDA 510(k) clearance for the Vivatmo pro. 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 February 22, 2024 after a review of 90 days - within the typical 510(k) review window.

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 - K233775

510(k) Number K233775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2023
Decision Date February 22, 2024
Days to Decision 90 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 88d · This submission: 90d
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 K233775.
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