FDA product code · Cardiovascular

Dc-Defibrillator, High Energy, (Including Paddles)

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

DRKClass III21 CFR 870.5300PMA required1 decision since 19930 recalls

1 FDA decision since 1993. No recall names this code.

PMA to be filed by 12/26/96 (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 DRK 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 · DRK

FDA has decided no DRK device since 2007.

Median 510(k) review, days · DRK

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

Recalls per year · DRK

No recall names DRK since 2007.

Adverse event reports per year · DRK

1in 2023

2007high 4 (2008) · low 0 (2009)2025

MAUDE reports naming product code DRK, 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	—	1
2008	—	4
2009	—	0
2010	—	0
2011	—	1
2012	—	0
2013	—	1
2014	—	0
2015	—	1
2016	—	0
2017	—	0
2018	—	0
2019	—	2
2020	—	0
2021	—	0
2022	—	0
2023	—	1
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in DRK? 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

Related product codes

Other codes under 21 CFR 870.5300.

LDD Dc-Defibrillator, Low-Energy, (Including…MPD Auxiliary Power Supply (Ac Or Dc) For…MPC Atrial Defibrillator

Dc-Defibrillator, High Energy, (Including Paddles)

What has FDA decided in DRK lately?

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