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Ladd/steritek ICP Monitor, Cat. No. P3000

by Ladd Research Industries, Inc.

510(k) K862820

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 NumberK862820 Date26 Feb 1987ClearedStatusActive

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  • Withdrawn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)

510(k) Number
FDA Product Code
GWM
Device Class
Class II
Regulation
21 CFR Part 882.1620
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Ladd/steritek ICP Monitor, Cat. No. P3000 is a device for monitoring intracranial pressure, classified under the neurology medical specialty. It is a substantially equivalent device cleared through the FDA 510(k) process under product code GWM and regulation number 882.1620.

This device is supplied as a non-sterile, reusable monitoring system intended for use in clinical settings to measure intracranial pressure. It requires no special storage conditions beyond standard environmental controls and is not indicated for MRI environments based on the provided data.

Other devices from Ladd Research Industries, Inc.

Questions

AI-generated answers, 27 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 Ladd/steritek ICP Monitor, Cat. No. P3000 used for?

    The Ladd/steritek ICP Monitor, Cat. No. P3000 is used for monitoring intracranial pressure in clinical settings, specifically within the neurology medical specialty, as indicated in the device description.

  • Is the Ladd/steritek ICP Monitor, Cat. No. P3000 sterile or non-sterile, and is it reusable?

    The device is supplied as a non-sterile, reusable monitoring system, meaning it is not provided in a sterile condition and is intended for multiple uses after appropriate reprocessing, as stated in the specifications.

  • What storage conditions are required for the Ladd/steritek ICP Monitor, Cat. No. P3000?

    The device requires no special storage conditions beyond standard environmental controls, indicating it can be stored under typical room temperature and humidity conditions found in clinical environments.

  • How was the Ladd/steritek ICP Monitor, Cat. No. P3000 cleared for market release?

    The device was cleared through the FDA 510(k) process as a substantially equivalent device, with product code GWM and regulation number 882.1620, based on the authorization and decision details provided.