FDA product code · Cardiovascular

Amplifier And Signal Conditioner, Biopotential

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

DRRClass II21 CFR 870.2050510(k) required24 decisions since 19760 recalls

24 FDA decisions since 1976. No recall names this code. The most-cited predicate is K971570, named by 1 later device.

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 DRR 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 · DRR

FDA has decided no DRR device since 2007.

Median 510(k) review, days · DRR

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

Recalls per year · DRR

No recall names DRR since 2007.

Adverse event reports per year · DRR

1in 2008

2007high 1 (2008) · low 0 (2007)2025

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

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

Planning a device in DRR? 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

Amplifier And Signal Conditioner, Biopotential

Which predicates do DRR devices cite most?

Which DRR devices have the deepest lineage?

What has FDA decided in DRR lately?