PGJClass II

Oximeter, Wellness

21 CFR 870.2700 / Cardiovascular

PGJ is the FDA product code for Oximeter, Wellness, a class II device type, regulated under 21 CFR 870.2700. FDA's definition for this code reads: "Pulse oximeter intended for wellness use". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: PGJ
Device name: Oximeter, Wellness
FDA definition: Pulse oximeter intended for wellness use.
Regulation: 21 CFR 870.2700
Device class: Class II
Review panel: Cardiovascular
Submission type: FDA code 7
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 37 companies shown, in name order

Recent clearances

Product code PGJ

FDA records hold no clearances under product code PGJ.

Recent recalls

Product code PGJ

FDA records show no recalls under product code PGJ.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)