510(k) Report

FDA product code · Physical medicine

Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation

QPYClass IIIPMA required1 decision since 20210 recalls

1 FDA decision since 2021. No recall names this code.

Stimulation of the vagus nerve

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, physical medicine panel

Twenty years of QPY 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 · QPY

7so far in 2026, the most since 2007

2021: 12022: 12024: 22025: 42026 (partial year): 7
2007high 7 (2026) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QPY

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

Recalls per year · QPY

No recall names QPY since 2007.

Adverse event reports per year · QPY

6in 2025

2023: 42024: 52025: 6
2007high 6 (2025) · low 0 (2007)2025

MAUDE reports naming product code QPY, 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—00
20160—00
20170—00
20180—00
20190—00
20200—00
20211—00
20221—00
20230—04
20242—05
20254—06
20267—0—
FIG. 1 — QPY by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QPY? 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