Skip to content

Peds Water Filled Catheter/Transducer System

by Medical Associated Services, Inc.

510(k) K893845

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK893845 Date27 Oct 1989ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
BZC
Device Class
Class II
Regulation
21 CFR Part 868.1880
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 Peds Water Filled Catheter/Transducer System is a medical device designed to facilitate pressure monitoring. It functions by utilizing a fluid-filled catheter connected to a transducer to measure physiological pressures.

This device has received FDA 510(k) clearance under K893845. It is classified as a class 2 medical device and is regulated under the anesthesiology specialty.

Other devices from Medical Associated Services, Inc.

Questions

AI-generated answers, 26 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 is the primary function of the Peds Water Filled Catheter/Transducer System?

    This device is designed to facilitate physiological pressure monitoring. It achieves this by utilizing a fluid-filled catheter that connects to a transducer to measure internal pressures.

  • What is the regulatory status of this device?

    The Peds Water Filled Catheter/Transducer System has received FDA 510(k) clearance under K893845. It is classified as a class 2 medical device regulated under the anesthesiology specialty.

  • Which medical specialty is this system associated with?

    This device is regulated under the anesthesiology specialty, as indicated by its classification and the advisory committee oversight during its regulatory filing process.