FDA product code · Cardiovascular

Photoplethysmograph Analysis Software For Over-The-Counter Use

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

QDBClass II21 CFR 870.2790510(k) required5 decisions since 20180 recalls

5 FDA decisions since 2018. 510(k) reviews decided 2021–2025 took a median of 126 days (half between 84 and 187). No recall names this code. The most-cited predicate is DEN180042, named by 3 later devices.

A photoplethysmograph analysis software device for over-the-counter use analyzes photoplethysmograph data and provides information for identifying irregular heart rhythms. This device is not intended to provide a diagnosis.

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 QDB 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 · QDB

1in 2023

2007high 2 (2022) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QDB

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

Recalls per year · QDB

No recall names QDB since 2007.

Adverse event reports per year · QDB

1in 2025

2007high 1 (2025) · low 0 (2007)2025

MAUDE reports naming product code QDB, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	1	—	0
2019	0	—	0
2020	0	—	0
2021	1	—	0
2022	2	—	0
2023	1	—	0
2024	0	—	0
2025	0	—	1
2026	0	—	—

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

Planning a device in QDB? 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 870.2790.

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Photoplethysmograph Analysis Software For Over-The-Counter Use

Which predicates do QDB devices cite most?

Which QDB devices have the deepest lineage?

What has FDA decided in QDB lately?

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