FDA product code · Microbiology

Test, Anti-Tumor Cell Susceptibility

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

MHRClass IIIPMA required1 decision since 19960 recalls

1 FDA decision since 1996. No recall names this code.

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, microbiology panel

Twenty years of MHR 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 · MHR

FDA has decided no MHR device since 2007.

Median 510(k) review, days · MHR

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

Recalls per year · MHR

No recall names MHR since 2007.

Adverse event reports per year · MHR

No MAUDE report names MHR since 2007.

View these four charts as a table

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

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

Planning a device in MHR? 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

Test, Anti-Tumor Cell Susceptibility

What has FDA decided in MHR lately?