510(k) Report

FDA product code · General hospital

Fall Prevention Alarm/Sensor Attached Only

PJPClass I21 CFR 880.2400510(k) exempt0 decisions0 recalls

FDA lists PJP 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.

This fall-prevention alarm/sensor works only when it is attached to a person. It attaches to a person usually by a clip or belt .

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 PJP 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 · PJP

FDA has decided no PJP device since 2007.

Median 510(k) review, days · PJP

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

Recalls per year · PJP

No recall names PJP since 2007.

Adverse event reports per year · PJP

3in 2024

2018: 62019: 62020: 42021: 22022: 42023: 82024: 3
2007high 8 (2023) · low 0 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—06
20190—06
20200—04
20210—02
20220—04
20230—08
20240—03
20250—00
20260—0—
FIG. 1 — PJP by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PJP? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

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Related product codes

Other codes under 21 CFR 880.2400.