Siemens Elema Models 4020T and 4021T Adapters

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K900512 ↗

FDA Product Code

DTD

Device Class

Class II

Regulation

21 CFR Part 870.3620

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• What are the Siemens Elema Models 4020T and 4021T Adapters used for?

  These adapters connect pacemaker leads to external pacing systems, ensuring proper electrical coupling during cardiac pacing procedures. They are specifically designed for use in clinical settings like electrophysiology labs or cardiac catheterization suites, where reliable lead-to-system compatibility is critical for safe pacemaker function.

• Are the Siemens Elema 4020T and 4021T Adapters single-use or reusable?

  These adapters are supplied as reusable medical devices. Reusability is common for components like these in cardiac procedures, as they undergo rigorous cleaning and sterilization protocols between uses to maintain safety and performance standards.

• What regulatory pathway do these adapters follow?

  The Siemens Elema Models 4020T and 4021T Adapters are classified as Class II devices under FDA 510(k) clearance (K900512). This pathway ensures they meet established safety and effectiveness standards for pacemaker lead adaptors, with a decision of substantial equivalence to a predicate device.

• What clinical environments are these adapters intended for?

  These adapters are designed for use in specialized clinical settings where cardiac pacing is performed, such as electrophysiology labs or cardiac catheterization suites. Their purpose is to facilitate secure and reliable connections during procedures requiring external pacing system integration.

• Are there any specific sterility or MRI safety details provided for these adapters?

  The available data does not include explicit information regarding sterility requirements or MRI safety for the Siemens Elema Models 4020T and 4021T Adapters. Clinicians should follow standard protocols for cleaning, sterilization, and MRI compatibility based on their facility’s guidelines and the specific device materials.