510(k) Report

FDA product code · Cardiovascular

Amplifier And Signal Conditioner, Transducer Signal

DRQClass II21 CFR 870.2060510(k) required27 decisions since 19760 recalls

27 FDA decisions since 1976. No recall names this code. The most-cited predicate is K010640, named by 5 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 DRQ 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 · DRQ

1in 2017

2015: 22017: 1
2007high 2 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRQ

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

Recalls per year · DRQ

No recall names DRQ since 2007.

Adverse event reports per year · DRQ

3in 2025

2015: 12016: 22017: 32018: 12020: 52021: 42022: 62023: 82024: 52025: 3
2007high 8 (2023) · low 0 (2007)2025

MAUDE reports naming product code DRQ, 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
20152—01
20160—02
20171—03
20180—01
20190—00
20200—05
20210—04
20220—06
20230—08
20240—05
20250—03
20260—0—
FIG. 1 — DRQ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in DRQ? 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