FDA product code · Clinical chemistry

Continuous Glucose Monitor Secondary Display

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

PJTClass II21 CFR 862.1350510(k) exempt2 decisions since 20150 recalls

FDA lists PJT as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 862.9 applies, such as a new intended use or a different fundamental technology. 2 FDA decisions since 2015. No recall names this code. The most-cited predicate is DEN140038, named by 1 later device.

The purpose of the continuous glucose monitor secondary display is to notify another person, the follower, of the patient's continuous glucose monitoring system sensor glucose information in real time. The secondary display is intended for providing secondary notification of a continuous glucose monitoring system and does not replace primary real time continuous glucose monitoring or standard home blood glucose…

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, clinical chemistry panel

Twenty years of PJT 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 · PJT

1in 2015

2007high 1 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PJT

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

Recalls per year · PJT

No recall names PJT since 2007.

Adverse event reports per year · PJT

3in 2025

2007high 9 (2021) · low 0 (2007)2025

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

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	1	—	0
2016	0	—	2
2017	0	—	2
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	9
2022	0	—	7
2023	0	—	2
2024	0	—	8
2025	0	—	3
2026	0	—	—

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

Planning a device in PJT? 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 862.1350.

PKU Insulin Pump Secondary Display

Continuous Glucose Monitor Secondary Display

Which predicates do PJT devices cite most?

Which PJT devices have the deepest lineage?

What has FDA decided in PJT lately?

Related product codes