FDA product code · Cardiovascular

Adjunctive Open Loop Fluid Therapy Recommender

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

QMSClass II21 CFR 870.5600510(k) required2 decisions since 20200 recalls

2 FDA decisions since 2020. 510(k) reviews decided 2021–2025 took a median of 228 days (half between 228 and 228). No recall names this code. The most-cited predicate is DEN190029, named by 1 later device.

The adjunctive open loop fluid therapy recommender is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict a patient’s estimated response to fluid therapy. The device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.

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 QMS 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 · QMS

1in 2024

2007high 1 (2020) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QMS

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

Recalls per year · QMS

No recall names QMS since 2007.

Adverse event reports per year · QMS

No MAUDE report names QMS since 2007.

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	0	—	0
2019	0	—	0
2020	1	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	1	—	0
2025	0	—	0
2026	0	—	—

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

Planning a device in QMS? 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

Adjunctive Open Loop Fluid Therapy Recommender

Which predicates do QMS devices cite most?

Which QMS devices have the deepest lineage?

What has FDA decided in QMS lately?