FDA product code · Cardiovascular

Sizer, Heart-Valve, Prosthesis

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

DTIClass I21 CFR 870.3945510(k) exempt7 decisions since 19800 recalls

FDA lists DTI 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. 7 FDA decisions since 1980. 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 DTI 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 · DTI

FDA has decided no DTI device since 2007.

Median 510(k) review, days · DTI

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

Recalls per year · DTI

No recall names DTI since 2007.

Adverse event reports per year · DTI

1in 2025

2007high 84 (2008) · low 1 (2017)2025

MAUDE reports naming product code DTI, 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	—	6
2008	—	84
2009	—	23
2010	—	4
2011	—	2
2012	—	2
2013	—	5
2014	—	6
2015	—	5
2016	—	7
2017	—	1
2018	—	1
2019	—	1
2020	—	1
2021	—	4
2022	—	2
2023	—	27
2024	—	7
2025	—	1
2026	—	—

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

Planning a device in DTI? 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

Sizer, Heart-Valve, Prosthesis

What has FDA decided in DTI lately?