FDA product code · Cardiovascular

Adjunctive Cardiovascular Status Indicator

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

PPWClass II21 CFR 870.2200510(k) required8 decisions since 20160 recalls

8 FDA decisions since 2016. 510(k) reviews decided 2021–2025 took a median of 260 days (half between 219 and 264). No recall names this code. The most-cited predicate is K213230, named by 3 later devices.

The adjunctive cardiovascular status indicator is a prescription device based on sensor technology for the measurement of a physical parameter(s). This 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 PPW 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 · PPW

2in 2025

2007high 2 (2022) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PPW

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

Recalls per year · PPW

No recall names PPW since 2007.

Adverse event reports per year · PPW

No MAUDE report names PPW 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	1	—	0
2017	0	—	0
2018	1	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	2	—	0
2023	1	—	0
2024	0	—	0
2025	2	—	0
2026	1	—	—

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

Planning a device in PPW? 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 870.2200.

QUO Adjunctive Heart Failure Status Indicator QXZ Adjunctive Epicardial Vascular Physiologic…SDJ Adjunctive Cardiac Amyloidosis Status Indicator

Adjunctive Cardiovascular Status Indicator

Which predicates do PPW devices cite most?

Which PPW devices have the deepest lineage?

What has FDA decided in PPW lately?

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