FDA product code · Clinical chemistry

System, Breath Measurement

Name: FDA decisions, review times, recalls and adverse event reports for product code NRH
Creator: 510(k) Report

NRHClass I21 CFR 862.1820510(k) exempt4 decisions since 19883 recalls

FDA lists NRH as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 862.9 applies, such as a new intended use or a different fundamental technology. 4 FDA decisions since 1988. 3 recalls name this code, 0 of them Class I. The most-cited predicate is K963376, named by 1 later device.

Breath measurement systems are used to measure constituents of exhaled breath as an aid in the diagnosis of sugar/nutrient malabsorbtion and other conditions.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, clinical chemistry panel

Twenty years of NRH at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · NRH

FDA has decided no NRH device since 2007.

Median 510(k) review, days · NRH

Too few NRH 510(k)s in any year since 2007 to give a median.

Recalls per year · NRH

3in 2025

2007high 3 (2025) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NRH

No MAUDE report names NRH since 2007.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	0	0
2009	—	0	0
2010	—	0	0
2011	—	0	0
2012	—	0	0
2013	—	0	0
2014	—	0	0
2015	—	0	0
2016	—	0	0
2017	—	0	0
2018	—	0	0
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	0
2023	—	0	0
2024	—	0	0
2025	—	3	0
2026	—	0	—

FIG. 1 — NRH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NRH? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 862.1820.

JQM P-Bromoaniline, Xylose JOC Colorimetric, Xylose

System, Breath Measurement

Which predicates do NRH devices cite most?

Which NRH devices have the deepest lineage?

What has FDA decided in NRH lately?

What has been recalled in NRH lately?

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