Apex Medical CPAP RT 21XX

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K022650 ↗

FDA Product Code

BZD

Device Class

Class II

Regulation

21 CFR Part 868.5905

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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  Class II

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  Class I

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• Acu-Stim Tens, Ap-101082T

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  FDA 510(k) K973980 Active Cleared 29 Jul 1998

• Apex Medical Digital TENS TS1211, TS1212

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• WiZARD 510 Nasal Mask

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  Class II

  FDA 510(k) K973978 Active Cleared 29 Jul 1998

See all devices from Apex Medical Corp. →

• What is the Apex Medical CPAP RT 21XX used for?

  The Apex Medical CPAP RT 21XX is a non-continuous ventilator (respirator) intended to provide controlled breaths to patients requiring respiratory support. It is specifically designed for use in clinical settings like operating rooms or intensive care units, where precise ventilation assistance is critical, particularly during surgical procedures or critical care scenarios.

• Is the Apex Medical CPAP RT 21XX a single-use or reusable device?

  The Apex Medical CPAP RT 21XX is supplied as a reusable medical instrument. This classification allows for multiple uses after proper cleaning, disinfection, and maintenance, ensuring cost-effectiveness and sustainability in clinical environments.

• What regulatory pathway does the Apex Medical CPAP RT 21XX follow?

  The Apex Medical CPAP RT 21XX is regulated under the FDA’s 510(k) clearance pathway, specifically with clearance number K022650. It is classified as a Class II device and is intended for use in managing patients’ breathing during controlled clinical procedures, adhering to FDA regulation 868.5905.

• Does the Apex Medical CPAP RT 21XX have any specific sterility or MRI safety information?

  The available data for the Apex Medical CPAP RT 21XX does not provide explicit details regarding sterility or MRI safety. Clinicians should follow standard operating procedures for cleaning, disinfection, and maintenance to ensure safe reuse. For MRI compatibility, additional manufacturer guidelines or testing should be consulted.

• What clinical specialties primarily use the Apex Medical CPAP RT 21XX?

  The Apex Medical CPAP RT 21XX is primarily intended for use in anesthesiology, where precise respiratory support is essential during surgical interventions or critical care scenarios. Its design aligns with the needs of operating rooms and intensive care units.