Heritage Nasal CPAP System, Model P/N 15682

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

510(k) Number

K990856 ↗

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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• What clinical settings is the Heritage Nasal CPAP System primarily designed for use in, and why is it suitable for these environments?

  The Heritage Nasal CPAP System is designed for use in anesthesia and respiratory support applications, specifically in operating rooms and recovery areas. It is suitable for these environments because it delivers continuous positive airway pressure (CPAP) to maintain open airways during spontaneous breathing, which is critical during surgical procedures and post-operative recovery to prevent airway collapse.

• Is the Heritage Nasal CPAP System intended for single-use or repeated use, and what does this mean for clinical workflows?

  The Heritage Nasal CPAP System is intended for single-use in clinical settings. This means each unit is designed to be used once per patient and then discarded, which helps reduce the risk of cross-contamination between patients and simplifies clinical workflows by eliminating the need for reprocessing or sterilization between uses.

• How should the Heritage Nasal CPAP System be stored, and are there any special conditions to consider?

  The Heritage Nasal CPAP System requires no special storage conditions beyond those recommended for standard medical devices. Since it is supplied sterile, it should be stored in a clean, dry environment, protected from physical damage and contamination, to maintain its integrity until use.

• What regulatory pathway was followed for FDA clearance of the Heritage Nasal CPAP System, and what does this indicate about its safety and equivalence?

  The Heritage Nasal CPAP System received FDA 510(k) clearance (K990856) under the Traditional 510(k) pathway, affirming its substantial equivalence to a predicate device. This clearance was reviewed by the FDA’s Anesthesiology (AN) Advisory Committee, indicating that the device met regulatory standards for safety and performance in its intended use for anesthesia and respiratory support applications.

• What is the primary purpose of the Heritage Nasal CPAP System, and how does it differ from a traditional ventilator?

  The Heritage Nasal CPAP System is a non-continuous ventilator specifically designed to deliver continuous positive airway pressure (CPAP) to maintain open airways during spontaneous breathing. Unlike traditional ventilators, which assist or control breathing cycles, this device focuses solely on applying steady pressure to prevent airway collapse, making it ideal for scenarios where patients breathe on their own but require airway support, such as in anesthesia or post-operative care.