510(k) Report

FDA product code · Cardiovascular

Stimulator, Carotid Sinus Nerve

DSRClass III21 CFR 870.3850PMA required1 decision since 20190 recalls

1 FDA decision since 2019. No recall names this code.

Call for PMAs 12/26/96 (61 FR 50706 (9/27/96))

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 DSR 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 · DSR

3in 2025

2019: 12021: 12022: 62023: 32024: 22025: 3
2007high 6 (2022) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DSR

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

Recalls per year · DSR

No recall names DSR since 2007.

Adverse event reports per year · DSR

136in 2025

2015: 12016: 12017: 32018: 12019: 12021: 52022: 242023: 602024: 932025: 136
2007high 136 (2025) · low 0 (2007)2025

MAUDE reports naming product code DSR, 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—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—01
20160—01
20170—03
20180—01
20191—01
20200—00
20211—05
20226—024
20233—060
20242—093
20253—0136
20260—0—
FIG. 1 — DSR by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in DSR? 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