FDA product code · General hospital

Fall Prevention Alarm/Sensor Combination Attached Or Unattached

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

PJOClass I21 CFR 880.2400510(k) exempt0 decisions0 recalls

FDA lists PJO as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 880.9 applies, such as a new intended use or a different fundamental technology. 0 FDA decisions. No recall names this code.

The fall-prevention alarm/sensor is a combination device that can attach to a person usually by a clip or belt OR it can be used unattached to the person, where the person sits upon it.

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, general hospital panel

Twenty years of PJO 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 · PJO

FDA has decided no PJO device since 2007.

Median 510(k) review, days · PJO

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

Recalls per year · PJO

No recall names PJO since 2007.

Adverse event reports per year · PJO

2in 2025

2007high 100 (2019) · low 0 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	4
2016	—	3
2017	—	7
2018	—	82
2019	—	100
2020	—	46
2021	—	29
2022	—	20
2023	—	20
2024	—	16
2025	—	2
2026	—	—

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

Planning a device in PJO? 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 880.2400.

SBO Bed-Patient Activity Monitoring System KMI Monitor, Bed Patient PJP Fall Prevention Alarm/Sensor Attached Only