Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart C — Cardiovascular Monitoring Devices](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices) → [21 CFR 870.2620](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2620) → DRI — Monitor, Line Isolation

# DRI · Monitor, Line Isolation

_Cardiovascular · 21 CFR 870.2620 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRI

## Overview

- **Product Code:** DRI
- **Device Name:** Monitor, Line Isolation
- **Regulation:** [21 CFR 870.2620](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2620)
- **Device Class:** 1
- **Review Panel:** [Cardiovascular](/submissions/CV)

## Identification

A line isolation monitor is a device used to monitor the electrical leakage current from a power supply electrically isolated from the commercial power supply received from a utility company.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K902493](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRI/K902493.md) | CARDIOCAP II CG-2GS, 2G, 1GS, 1G, 2CG, CS MONITOR | Datex Division Instrumentarium Corp. | Jul 6, 1990 | SESE |
| [K902492](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRI/K902492.md) | CARDIOCAP II MONITORS: CH, CH-2, CH-S, CH-2S | Datex Division Instrumentarium Corp. | Jul 6, 1990 | SESE |
| [K822316](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRI/K822316.md) | HEART MONITOR BRACELET ALARM | Hmba | Sep 21, 1982 | SESE |
| [K802326](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRI/K802326.md) | PRESSURE MONITORING LINES | Stanco Medical, Inc. | Oct 10, 1980 | SESE |

## Top Applicants

- Datex Division Instrumentarium Corp. — 2 clearances
- Hmba — 1 clearance
- Stanco Medical, Inc. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRI](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRI)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com