Cleared Traditional

K203695 - NObreath

K203695 is an FDA 510(k) clearance for NObreath, manufactured by Bedfont Scientific, Ltd.. The device is a Class 2 Chemistry device with product code MXA cleared through the Traditional 510(k) pathway after a 364-day FDA review.

K203695 · Bedfont Scientific, Ltd. · Chemistry device
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Dec 2021
Decision
364d
Days
Class 2
Risk

K203695 is an FDA 510(k) clearance for the NObreath®. Classified as System, Test, Breath Nitric Oxide (product code MXA), Class II - Special Controls.

Submitted by Bedfont Scientific, Ltd. (Maidstone, Kent, GB). The FDA issued a Cleared decision on December 17, 2021 after a review of 364 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Bedfont Scientific, Ltd. devices

FDA 510(k) Submission Details - K203695

510(k) Number K203695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2020
Decision Date December 17, 2021
Days to Decision 364 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
276d slower than avg
Panel avg: 88d · This submission: 364d
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 Consultant

Bedfont Scientific, LLC C/O Promedic, LLC
Paul Dryden

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.