FDA product code · Cardiovascular

Clip, Vena-Cava

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

DSTClass II21 CFR 870.3260510(k) required1 decision since 19900 recalls

1 FDA decision since 1990. 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 DST 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 · DST

FDA has decided no DST device since 2007.

Median 510(k) review, days · DST

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

Recalls per year · DST

No recall names DST since 2007.

Adverse event reports per year · DST

No MAUDE report names DST 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 — DST by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in DST? 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

Clip, Vena-Cava

What has FDA decided in DST lately?