Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1450](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1450) → DXM — Densitometer

# DXM · Densitometer

_Cardiovascular · 21 CFR 870.1450 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXM

## Overview

- **Product Code:** DXM
- **Device Name:** Densitometer
- **Regulation:** [21 CFR 870.1450](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1450)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **3rd-party reviewable:** yes

## Identification

A densitometer is a device used to measure the transmission of light through an indicator in a sample of blood.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K791892](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXM/K791892.md) | TAPE-A-TRACE | Instromedix, Inc. | Nov 5, 1979 | SESE |
| [K781692](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXM/K781692.md) | CALIBRATOR, DYNAMIC | Waters Assoc., Inc. | Nov 29, 1978 | SESE |

## Top Applicants

- Instromedix, Inc. — 1 clearance
- Waters Assoc., Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXM](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXM)

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