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Siemens Sirecust Transcutaneous Carbon Dioxide

by Siemens Medical Electronics

510(k) K891481

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 NumberK891481 Date29 Sep 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  • Withdrawn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
LKD
Device Class
Class II
Regulation
21 CFR Part 868.2480
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Siemens Sirecust Transcutaneous Carbon Dioxide is a monitor used in anesthesiology to measure carbon dioxide levels. It is classified as a class 2 device and is regulated under the regulation number 868.2480. The device is substantially equivalent to other devices on the market.

The device is supplied by Siemens Medical Electronics and has been granted FDA 510(k) clearance under the number K891481. It is available with a product code of LKD and has a device class of 2. The device is used in the medical specialty of anesthesiology and is intended for use in a clinical setting.

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Questions

AI-generated answers, 24 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 Sirecust Transcutaneous CO2 Monitor used for?

    The Sirecust Transcutaneous CO2 Monitor is used to measure carbon dioxide levels in patients, primarily in the medical specialty of anesthesiology.

  • Is the Sirecust Transcutaneous CO2 Monitor a single-use device?

    The device data does not specify whether the Sirecust Transcutaneous CO2 Monitor is single-use or reusable, but it is intended for use in a clinical setting.

  • What is the regulatory classification of the Sirecust Transcutaneous CO2 Monitor?

    The Sirecust Transcutaneous CO2 Monitor is classified as a class 2 device, regulated under the regulation number 868.2480.

  • What is the product code for the Sirecust Transcutaneous CO2 Monitor?

    The product code for the Sirecust Transcutaneous CO2 Monitor is LKD.