FDA product code · Cardiovascular

Alarm, Leakage Current, Portable

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

DSMClass I21 CFR 870.2640510(k) exempt1 decision since 19780 recalls

FDA lists DSM as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 870.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision since 1978. 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, cardiovascular panel

Twenty years of DSM 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 · DSM

FDA has decided no DSM device since 2007.

Median 510(k) review, days · DSM

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

Recalls per year · DSM

No recall names DSM since 2007.

Adverse event reports per year · DSM

1in 2009

2007high 1 (2009) · low 0 (2007)2025

MAUDE reports naming product code DSM, 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	—	0
2009	—	1
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 — DSM by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in DSM? 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

Alarm, Leakage Current, Portable

What has FDA decided in DSM lately?