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Ultima Snoring Mike Model 0540

FDA 510(k)

Class II (US FDA 510(k))

510(k) K020312

by Braebon Medical Corp.

Identifiers

510(k) Number
K020312 FDA 510(k)
FDA Product Code
MNR FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.2375 FDA 510(k)
Regulation Number
868.2375 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Ultima Snoring Mike Model 0540 is a Ventilatory Effort Recorder, designed to detect and monitor snoring sounds during anesthesia. It functions as a specialized microphone to capture respiratory effort, aiding in the assessment of airway patency and ventilatory status in clinical settings.

This device is intended for single-use in anesthesia environments and is classified as a Class II medical device under FDA regulation 868.2375. Supplied sterile, it is regulated under the FDA 510(k) clearance (K020312) with a decision date of August 7, 2002, and is intended for use in anesthesiology. No MRI safety or reusable specifications are noted.

Frequently asked questions

What clinical setting is the Ultima Snoring Mike Model 0540 intended for use in, and how does it assist clinicians?

The Ultima Snoring Mike Model 0540 is designed specifically for use in anesthesia environments, where it functions as a ventilatory effort recorder to detect and monitor snoring sounds during procedures. By capturing respiratory effort, it helps clinicians assess airway patency and ventilatory status, ensuring patient safety during anesthesia.

Is the Ultima Snoring Mike Model 0540 reusable, or is it meant for single-use only? How does this affect its handling?

The device is explicitly intended for single-use in anesthesia settings. This means it should not be reused after one procedure, reducing the risk of contamination and ensuring sterile conditions for patient safety. Proper disposal after use is required.

How is the Ultima Snoring Mike Model 0540 supplied, and is it sterile upon receipt?

The device is supplied sterile, meaning it is packaged and prepared for immediate clinical use without additional sterilization. This ensures readiness for deployment in anesthesia environments where maintaining sterility is critical.

What regulatory pathway was followed for FDA clearance of the Ultima Snoring Mike Model 0540, and when was it approved?

The device underwent FDA 510(k) clearance through a traditional review process, with the Anesthesiology (AN) Advisory Committee providing input. It was deemed substantially equivalent to a predicate device and received clearance on August 7, 2002, under the classification of a Class II medical device (FDA regulation 868.2375).

Are there any special storage requirements for the Ultima Snoring Mike Model 0540 before use?

While the provided data does not specify detailed storage conditions, since the device is sterile and single-use, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Follow manufacturer guidelines to maintain its integrity until use.

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: ULTIMA SNORING MIKE, MODEL 0540 (K020312) — FDA 510(k) | Innolitics, ULTIMA SNORING MIKE, MODEL 0540 510(k) K020312 - FDA.report, BRAEBON Ultima Snore Microphone - mvapmed.com, Braebon - Snore Measurement

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Braebon Medical Corp.

Sources (1)

  • FDA 510(k) K020312 24 fields · synced Sep 19, 2026