DXMClass II

Densitometer

21 CFR 870.1450 / Cardiovascular

DXM is the FDA product code for Densitometer, a class II device type, regulated under 21 CFR 870.1450. As of 2026-09-10, FDA records hold 2 510(k) clearances under this code, the most recent dated 1979-11-05, and no recalls.

Classification record

Product code: DXM
Device name: Densitometer
Regulation: 21 CFR 870.1450
Device class: Class II
Review panel: Cardiovascular
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 2
Ingested recalls: 0

Clearances, product code DXM

By decision year

2 clearances under product code DXM with a decision year between 1978 and 1979, 1978 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code DXM by decision year
Year	Clearances
1978	1
1979	1

Applicants with the most clearances

Product code DXM

Applicants holding the most 510(k) clearances under product code DXM
Applicant	Clearances
Instromedix, Inc.	1
Waters Assoc., Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code DXM.

Recent clearances

Product code DXM

Recent recalls

Product code DXM

FDA records show no recalls under product code DXM.

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)