FDA product code · Cardiovascular

Adjunctive Hemodynamic Indicator With Decision Point For Military Use

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

SARClass II21 CFR 870.2220510(k) required1 decision since 20240 recalls

1 FDA decision since 2024. 510(k) reviews decided 2021–2025 took a median of 190 days (half between 190 and 190). No recall names this code.

An adjunctive hemodynamic indicator with decision point is a device that identifies and monitors hemodynamic condition(s) of interest and provides notifications at a clinically meaningful decision point. This device is intended to be used adjunctively along with other monitoring and patient information. The device is intended for use by the Military.

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 SAR 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 · SAR

1in 2024

2007high 1 (2024) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · SAR

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

Recalls per year · SAR

No recall names SAR since 2007.

Adverse event reports per year · SAR

No MAUDE report names SAR 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	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	1	—	0
2025	0	—	0
2026	0	—	—

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

Planning a device in SAR? 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

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Other codes under 21 CFR 870.2220.

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Adjunctive Hemodynamic Indicator With Decision Point For Military Use

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