Minime Pediatric Mask

FDA 510(k)

Class II (US FDA 510(k))

510(k) K090935

Identifiers

510(k) Number: K090935 FDA 510(k)
FDA Product Code: BZD FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 868.5905 FDA 510(k)
Regulation Number: 868.5905 FDA 510(k)
Advisory Committee: Anesthesiology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The Minime Pediatric Mask is a ventilator, non-continuous respirator mask designed for pediatric use. It is intended to provide a comfortable and non-invasive interface for respiratory therapy. The device is designed for children ages 2-12.

The Minime Pediatric Mask is supplied with FDA 510K authorization and is classified under regulation number 868.5905. It is a single-use device, and its storage and use should follow the manufacturer's instructions. The device is available in various sizes to accommodate different pediatric patients.

Frequently asked questions

What is the Minime Pediatric Mask used for?

The Minime Pediatric Mask is used for respiratory therapy in pediatric patients, providing a comfortable and non-invasive interface.

Is the Minime Pediatric Mask a single-use device?

Yes, the Minime Pediatric Mask is a single-use device, and its storage and use should follow the manufacturer's instructions.

What ages is the Minime Pediatric Mask designed for?

The Minime Pediatric Mask is designed for children ages 2-12, and is available in various sizes to accommodate different pediatric patients.

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: MiniMe®2 Nasal Pediatric Mask - Sleepnet Corporation Respiratory NIV mask, MiniMe® Nasal Pediatric Mask - Sleepnet Corporation Respiratory NIV masks, MiniMe® Nasal Pediatric Masks by Sleepnet - Mercury Medical, Sleepnet - MiniMe - 60214 - Pediatric Mask With Headgear, Medium

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K090935	Class II	Active

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Manufacturer

Manufacturer: Sleepnet Corporation

Sources (1)

FDA 510(k) K090935 24 fields · synced Sep 21, 2026