Skip to content

Multi-Parameter Patient Monitor PMS8210A

by Shanghai 3f Electronics Co, Ltd.

510(k) K100394

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK100394 Date15 Apr 2010ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Multi-Parameter Patient Monitor, Model# PMS8210A
510(k) Number
FDA Product Code
MWI
Device Class
Class II
Regulation
21 CFR Part 870.2300
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Multi-Parameter Patient Monitor PMS8210A is a medical device classified as a multi-parameter patient monitor (Product Code MWI). It continuously measures and displays vital signs such as ECG, blood pressure, pulse oximetry, respiratory rate, and temperature to assess patient status in real time. Designed for critical care, it provides comprehensive physiological monitoring across adult, pediatric, and neonatal patients.

This device is intended for use in clinical settings such as intensive care units, emergency departments, and operating rooms. Supplied sterile or non-sterile based on clinical requirements, it may be reusable or single-use depending on facility protocols. The PMS8210A has been granted FDA 510(k) clearance under the Traditional pathway, with a decision date of April 15, 2010. No specific MRI safety classification or size variations are noted in the available data.

Other devices from Shanghai 3f Electronics Co, Ltd.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of patients can the PMS8210A monitor, and where is it typically used in a clinical setting?

    The PMS8210A is designed to monitor adult, pediatric, and neonatal patients by continuously tracking vital signs like ECG, blood pressure, pulse oximetry, respiratory rate, and temperature. It is intended for use in critical care environments such as intensive care units (ICUs), emergency departments, and operating rooms, where real-time physiological assessment is essential.

  • Is the PMS8210A available in sterile or non-sterile versions, and how should it be handled based on facility protocols?

    The PMS8210A can be supplied either sterile or non-sterile, depending on the clinical requirements of the facility. Whether it is single-use or reusable depends on the specific protocols established by the healthcare provider, as no default usage instructions are provided in the data.

  • What regulatory pathway was followed for FDA clearance of the PMS8210A, and when was the decision made?

    The PMS8210A received FDA 510(k) clearance under the Traditional pathway, with a decision date of April 15, 2010. This clearance was granted by the Cardiovascular (CV) advisory committee, confirming its substantial equivalence to a predicate device.

  • Does the PMS8210A come in different sizes or models, and is there any specific MRI safety information available?

    The available data does not specify any size variations or distinct model numbers beyond the PMS8210A itself. Additionally, there is no mention of MRI safety classification or compatibility, so users should verify compatibility with their facility’s MRI protocols before use.