FDA product code · Anesthesiology

Analyzer, Nitric Oxide

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

MRPClass II21 CFR 868.2380510(k) required1 decision since 20030 recalls

1 FDA decision since 2003. No recall names this code. The most-cited predicate is K023014, named by 1 later device.

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, anesthesiology panel

Twenty years of MRP 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 · MRP

FDA has decided no MRP device since 2007.

Median 510(k) review, days · MRP

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

Recalls per year · MRP

No recall names MRP since 2007.

Adverse event reports per year · MRP

2in 2024

2007high 11 (2014) · low 0 (2007)2025

MAUDE reports naming product code MRP, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	1
2009	—	0
2010	—	1
2011	—	8
2012	—	4
2013	—	7
2014	—	11
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	2
2025	—	0
2026	—	—

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

Planning a device in MRP? 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

Analyzer, Nitric Oxide

Which predicates do MRP devices cite most?

What has FDA decided in MRP lately?