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Transpac II Disposable Transducer

by Abbott Laboratories 510(k)

Active United States

510(k) K884823

Overview

The Transpac II Disposable Transducer is a medical device classified as a Monitoring Device for Intracranial Pressure, designed to measure and monitor intracranial pressure (ICP) in clinical settings. It provides real-time data critical for assessing and managing conditions such as traumatic brain injury, intracranial hemorrhage, or hydrocephalus by accurately transducing pressure signals.

This single-use, disposable device is intended for use in neurosurgical and critical care environments where sterile monitoring is required. Supplied sterile and packaged for one-time use, it connects to monitoring systems for continuous ICP assessment. The device adheres to FDA regulatory standards under 510(k) clearance (K884823) and is categorized under product code GWM, with no indication of MRI compatibility. Storage and handling follow standard sterile medical device protocols.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK884823 Date3 Jul 1990ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

4 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-0617-05 FDA Unclassified (pre-2012) initiated 2 Nov 2004 via K884823, on the same 510(k)
    • Terminated Z-0620-05 FDA Unclassified (pre-2012) initiated 2 Nov 2004 via K884823, on the same 510(k)
    • Terminated Z-0618-05 FDA Unclassified (pre-2012) initiated 2 Nov 2004 via K884823, on the same 510(k)
    • Terminated Z-0619-05 FDA Unclassified (pre-2012) initiated 2 Nov 2004 via K884823, on the same 510(k)

    Syringes could possibly allow air to enter the patient's vascular system.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

510(k)

Full name
Transpac(R) Ii, Disposable Transducer
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

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Questions

  • What clinical conditions is the Transpac II Disposable Transducer primarily used to monitor?

    The Transpac II Disposable Transducer is designed to measure and monitor intracranial pressure (ICP) in patients with conditions such as traumatic brain injury, intracranial hemorrhage, or hydrocephalus. Real-time ICP data helps clinicians assess and manage these critical neurological conditions effectively.

  • Is the Transpac II Disposable Transducer intended for single-use or reusable applications?

    The Transpac II Disposable Transducer is explicitly labeled as a single-use, disposable device. It is supplied sterile and packaged for one-time clinical use, ensuring sterile monitoring in neurosurgical and critical care settings.

  • How should the Transpac II Disposable Transducer be stored and handled?

    The device follows standard sterile medical device protocols for storage and handling. Since it is supplied sterile and disposable, it should be stored in its original packaging until use, protected from contamination, and handled with aseptic techniques to maintain sterility.

  • What regulatory pathway was followed for the Transpac II Disposable Transducer’s FDA clearance?

    The Transpac II Disposable Transducer received FDA clearance through a 510(k) submission (K884823) under the Traditional clearance type, with a decision of Substantially Equivalent (SESE). The device falls under product code GWM and was reviewed by the Neurology (NE) Advisory Committee.

  • Are there multiple sizes or models of the Transpac II Disposable Transducer available?

    The provided data lists multiple FEI numbers (e.g., 3014334038, 3013557562), which may correspond to different lot or batch identifiers rather than distinct sizes or models. However, no explicit size or model variations are described in the device details, suggesting a standardized design for intracranial pressure monitoring.