Identifiers
- 510(k) Number
- K924341 FDA 510(k)
- FDA Product Code
- BYT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5935 FDA 510(k)
- Regulation Number
- 868.5935 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Hayek Oscillator is a Negative Pressure Ventilator, External Body, Adult (Cuirass) designed for mechanical ventilation during anesthesia. It delivers controlled negative pressure to assist or replace spontaneous breathing, typically used in surgical settings where invasive ventilation is contraindicated or impractical. The device operates via a cuirass-style chest enclosure to generate oscillatory pressure changes, facilitating gas exchange without endotracheal intubation. Its classification under Anesthesiology reflects its primary role in perioperative respiratory support.
The Hayek Oscillator is supplied as a reusable medical device, intended for use in clinical environments such as operating rooms or recovery areas. It is regulated under FDA 510(k) clearance (K924341) and falls under Class II with product code BYT, adhering to 21 CFR 868.5935 for external body ventilators. No specific sterility requirements are noted in the data, but standard surgical cleaning and disinfection protocols apply. The device’s oscillatory mechanism requires proper calibration and maintenance to ensure accurate pressure delivery and patient safety.
Frequently asked questions
What types of clinical settings is the Hayek Oscillator designed for, and how does it differ from traditional ventilators?
The Hayek Oscillator is specifically designed for use in surgical settings, particularly during anesthesia, where invasive ventilation like endotracheal intubation is not suitable or practical. Unlike traditional positive-pressure ventilators that require intubation, it uses a cuirass-style chest enclosure to deliver controlled negative pressure externally, assisting or replacing spontaneous breathing without direct airway access. This makes it ideal for perioperative respiratory support where minimizing airway manipulation is critical.
Is the Hayek Oscillator a single-use or reusable device, and what cleaning protocols should be followed?
The Hayek Oscillator is a reusable medical device intended for clinical environments like operating rooms or recovery areas. While no specific sterility requirements are listed, standard surgical cleaning and disinfection protocols must be followed to ensure patient safety and device integrity between uses. Proper maintenance and calibration are also essential to guarantee accurate pressure delivery and reliable performance.
How is the regulatory status of the Hayek Oscillator determined, and what does its classification under FDA 510(k) clearance mean?
The Hayek Oscillator holds FDA 510(k) clearance (K924341), which means it has been determined to be substantially equivalent to a legally marketed device already on the market. This classification under FDA 510(k) indicates that the device meets regulatory standards for safety and effectiveness as defined by the FDA’s Center for Devices and Radiological Health. It falls under Class II and is regulated under 21 CFR 868.5935 for external body ventilators, ensuring it adheres to strict manufacturing and performance guidelines.
What is the primary purpose of the Hayek Oscillator, and why is it categorized under anesthesiology?
The Hayek Oscillator’s primary purpose is to provide mechanical ventilation during anesthesia by delivering controlled negative pressure via a cuirass-style chest enclosure. It is categorized under anesthesiology because its design and function are tailored for perioperative respiratory support, ensuring patients receive adequate ventilation without the need for endotracheal intubation—a critical advantage in surgical settings where airway management must be minimized.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: HAYEK OSCILLATOR(TM) (K924341) — FDA 510(k) | Innolitics, K924341 - HAYEK OSCILLATOR(TM) | FDA 510(k) | Respironics, Inc., HAYEK OSCILLATOR(TM) 510(k) K924341 - FDA.report, PDF K924341 - Hayek Oscillator(Tm), Hayek Oscillator (Tm) - Beudamed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K924341 | Class II | Active |
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Manufacturer
- Manufacturer
- Respironics, Inc.
Sources (1)
- FDA 510(k) K924341 24 fields · synced Sep 20, 2026