Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1100](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1100) → DSJ — Alarm, Blood-Pressure

# DSJ · Alarm, Blood-Pressure

_Cardiovascular · 21 CFR 870.1100 · Class 2_

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

## Overview

- **Product Code:** DSJ
- **Device Name:** Alarm, Blood-Pressure
- **Regulation:** [21 CFR 870.1100](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1100)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **3rd-party reviewable:** yes

## Identification

A blood pressure alarm is a device that accepts the signal from a blood pressure transducer amplifier, processes the signal, and emits an alarm when the blood pressure falls outside a pre-set upper or lower limit.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K190624](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSJ/K190624.md) | EarlyVue VS30 | Philips Medizin Systeme Boeblingen GmbH | Oct 27, 2019 | SESE |
| [K163649](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSJ/K163649.md) | SureSigns VS3; SureSigns VS4 | Philips Medical Systems | Mar 31, 2017 | SESE |
| [K151761](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSJ/K151761.md) | SureSigns VS3, SureSigns VS4 | Phillips Medical Systems | Sep 29, 2015 | SESE |
| [K133961](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSJ/K133961.md) | SURESIGNS VS3, SURESIGNS VS4 | Philips Medical Systems | Jun 26, 2014 | SESE |
| [K960916](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSJ/K960916.md) | SAMS 8000 CARDIOPLEGIA MONITOR | 3M Health Care, Sarns | Jun 4, 1996 | SESE |
| [K910262](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSJ/K910262.md) | KELLER VITAL SIGNS MONITOR - KMS-890 | Keller Medical Specialties Products, Inc. | Apr 1, 1991 | SESE |

## Top Applicants

- Philips Medical Systems — 2 clearances
- 3M Health Care, Sarns — 1 clearance
- Keller Medical Specialties Products, Inc. — 1 clearance
- Philips Medizin Systeme Boeblingen GmbH — 1 clearance
- Phillips Medical Systems — 1 clearance

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

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