Apex Medical XT1 CPAP, Model 9S-005

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

510(k) Number

K070609 ↗

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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See all devices from Apex Medical Corp. →

• What is the primary purpose of the Apex Medical XT1 CPAP?

  The Apex Medical XT1 CPAP is a non-continuous ventilator designed to deliver pressurized air to an adult patient via a mask interface. It is specifically indicated for the treatment of obstructive sleep apnea by maintaining airway patency during sleep.

• In what environments can this CPAP device be used?

  This device is intended for use in both home and clinical settings. Because it is a medical device, it must be used under the direction of a physician prescription.

• What is the regulatory status of the Apex Medical XT1 CPAP?

  The Apex Medical XT1 CPAP, model 9S-005, is authorized for use under FDA 510(k) clearance, which indicates it has been reviewed and cleared for the market based on its substantial equivalence to other legally marketed devices.