FDA product code · Cardiovascular

Materials, Repair Or Replacement, Pacemaker

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

KFJClass III21 CFR 870.3710PMA required3 decisions since 19820 recalls

3 FDA decisions since 1982. 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 KFJ 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 · KFJ

FDA has decided no KFJ device since 2007.

Median 510(k) review, days · KFJ

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

Recalls per year · KFJ

No recall names KFJ since 2007.

Adverse event reports per year · KFJ

2in 2023

2007high 6 (2011) · low 0 (2007)2025

MAUDE reports naming product code KFJ, 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	—	0
2008	—	0
2009	—	0
2010	—	1
2011	—	6
2012	—	1
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	2
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in KFJ? 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

Materials, Repair Or Replacement, Pacemaker

What has FDA decided in KFJ lately?