FDA product code · Anesthesiology

Oximeter, Wellness

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

PGJClass II21 CFR 870.27000 decisions0 recalls

0 FDA decisions. No recall names this code.

Pulse oximeter intended for wellness use.

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, anesthesiology panel

Twenty years of PGJ 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 · PGJ

FDA has decided no PGJ device since 2007.

Median 510(k) review, days · PGJ

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

Recalls per year · PGJ

No recall names PGJ since 2007.

Adverse event reports per year · PGJ

1in 2021

2007high 1 (2020) · low 0 (2007)2025

MAUDE reports naming product code PGJ, 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	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	1
2021	—	1
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in PGJ? 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 870.2700.

MUD Oximeter, Tissue Saturation NLF Oximeter, Reprocessed OLK Pulse Oximeter For Over-The-Counter Use DQA Oximeter OCH Oximeter, Infrared, Sporting, Aviation QEM Cerebral Oximeter NMD Oximeter, Tissue Saturation, Reprocessed