510(k) Report

FDA product code · Cardiovascular

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

JOQClass II21 CFR 870.1750510(k) required19 decisions since 19843 recalls

19 FDA decisions since 1984. 3 recalls name this code, 0 of them Class I. The most-cited predicate is K011826, 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 JOQ 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 · JOQ

1in 2018

2007: 22009: 12018: 1
2007high 2 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JOQ

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

Recalls per year · JOQ

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JOQ

5in 2025

2007: 82008: 22009: 32010: 112011: 92012: 252013: 12014: 32017: 42018: 32019: 42020: 22021: 22022: 42023: 102024: 82025: 5
2007high 25 (2012) · low 0 (2015)2025

MAUDE reports naming product code JOQ, 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
20072—08
20080—02
20091—13
20100—011
20110—09
20120—025
20130—01
20140—03
20150—00
20160—00
20170—04
20181—03
20190—04
20200—02
20210—02
20220—04
20230—010
20240—08
20250—05
20260—0—
FIG. 1 — JOQ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in JOQ? 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