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K Series CPAP Systems

by Curative Medical, Inc. 510(k)

Active United States

510(k) K130828

Overview

The K Series CPAP Systems are continuous positive airway pressure devices intended for the treatment of obstructive sleep apnea in spontaneously breathing patients weighing more than 30 kg. The system delivers a continuous positive airway pressure of 4 to 20 cm H2O and includes a humidifier. It is classified as a non-continuous ventilator (respirator) under device class 2.

The device is intended for use in home or hospital and institutional environments. It is regulated under regulation number 868.5905 and product code BZD. The system is associated with FDA 510(k) clearances including K130828 and K131702, with a substantially equivalent decision. The manufacturer is Curative Medical, Inc., based in Fulshear, TX, USA.

AI-generated from registry data, 25 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK130828 Date13 Jan 2014ClearedStatusActive

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

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
BZD
Device Class
Class II
Regulation
21 CFR Part 868.5905
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Other devices from Curative Medical, Inc.

Questions

  • What condition is the K Series CPAP System designed to treat?

    The K Series CPAP System is intended for the treatment of obstructive sleep apnea in spontaneously breathing patients weighing more than 30 kg. It provides continuous positive airway pressure to maintain airway patency during sleep.

  • What pressure range does the K Series CPAP System deliver?

    The device delivers a continuous positive airway pressure ranging from 4 to 20 cm H2O. This range allows for tailored therapy based on individual patient needs and prescription requirements.

  • Does the K Series CPAP System include a humidifier?

    Yes, the K Series CPAP System includes a humidifier as part of its integrated design. This helps soothe the airway and improve patient comfort during prolonged use by adding moisture to the delivered air.

  • In what environments is the K Series CPAP System intended for use?

    The K Series CPAP System is designed for use in both home and hospital or institutional environments. Its versatility supports patients requiring therapy in clinical settings as well as those using it at home for long-term management.

  • Is the K Series CPAP System classified as a ventilator?

    Yes, the K Series CPAP System is classified under device class 2 as a non-continuous ventilator (respirator). This classification reflects its function in delivering positive airway pressure without providing mechanical ventilation breaths.