510(k) Report

FDA product code · Cardiovascular

Occluder, Catheter Tip

DQTClass II21 CFR 870.1370510(k) required12 decisions since 19843 recalls

12 FDA decisions since 1984. 3 recalls name this code, 2 of them Class I. The most-cited predicate is K983927, named by 4 later devices.

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 DQT 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 · DQT

FDA has decided no DQT device since 2007.

Median 510(k) review, days · DQT

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

Recalls per year · DQT

2in 2013

2013: 2, 2 Class I
2007high 2 (2013) · low 0 (2007)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · DQT

1in 2025

2007: 32008: 52009: 22011: 42012: 12013: 32014: 22015: 62016: 22017: 42018: 122019: 212020: 112021: 22022: 52023: 42025: 1
2007high 21 (2019) · low 0 (2010)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—03
20080—05
20090—02
20100—00
20110—04
20120—01
20130—2 (2)3
20140—02
20150—06
20160—02
20170—04
20180—012
20190—021
20200—011
20210—02
20220—05
20230—04
20240—00
20250—01
20260—0—
FIG. 1 — DQT by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in DQT? 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