Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1140](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1140) → KRK — Manometer, Blood-Pressure, Venous

# KRK · Manometer, Blood-Pressure, Venous

_Cardiovascular · 21 CFR 870.1140 · Class 2_

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

## Overview

- **Product Code:** KRK
- **Device Name:** Manometer, Blood-Pressure, Venous
- **Regulation:** [21 CFR 870.1140](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1140)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **3rd-party reviewable:** yes

## Identification

A venous blood pressure manometer is a device attached to a venous catheter to indicate manometrically the central or peripheral venous pressure.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (9 of 9)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K950607](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRK/K950607.md) | UST-5268P-5 TRANSDUCER | Aloka Co., Ltd. | Sep 15, 1995 | SESE |
| [K904674](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRK/K904674.md) | CENTRAL VENOUS PRESSURE MANOMETER | Medex, Inc. | Dec 27, 1990 | SESE |
| [K884386](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRK/K884386.md) | ADMINISTRATION/MANOMETER SET W/3 WAY STOPCOCK | Ethitek Pharmaceuticals Co. | Jan 5, 1989 | SESE |
| [K875322](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRK/K875322.md) | MODIFIED SCHNEIDER-SHILEY PRESSURE MANOMETER | Schneider-Shilley (Usa) | Mar 28, 1988 | SESE |
| [K861605](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRK/K861605.md) | SCHNEIDER-SHILEY PRESSURE MANOMETER | Shiley, Inc. | May 28, 1986 | SESE |
| [K830910](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRK/K830910.md) | MANOMETER SET C.V.P. #S 298/299 | Exco, Inc. | Apr 5, 1983 | SESE |
| [K813498](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRK/K813498.md) | MEDIFIX | Burron Medical Products, Inc. | Jan 7, 1982 | SESE |
| [K813195](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRK/K813195.md) | MEDIFIX GRADUATED SCALE | Burron Medical Products, Inc. | Dec 29, 1981 | SESE |
| [K790668](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRK/K790668.md) | VENOUS PRESSURE MONITOR, MF 35 LF | Deco Medical, Inc. | May 23, 1979 | SESE |

## Top Applicants

- Burron Medical Products, Inc. — 2 clearances
- Aloka Co., Ltd. — 1 clearance
- Deco Medical, Inc. — 1 clearance
- Ethitek Pharmaceuticals Co. — 1 clearance
- Exco, Inc. — 1 clearance

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

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