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Resuscitation Unit 105

FDA 510(k)

Class II (US FDA 510(k))

510(k) K103317

by Atom Medical Corporation

Identifiers

510(k) Number
K103317 FDA 510(k)
FDA Product Code
BZR FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.5330 FDA 510(k)
Regulation Number
868.5330 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Resuscitation Unit 105 is a Mixer, Breathing Gases, Anesthesia Inhalation designed to remove secretions from neonatal or infant airways while delivering blended air and oxygen at adjustable concentrations (21–100%) to respiratory assist devices, including ventilators and oxygen tents. It functions as a critical component in neonatal resuscitation by facilitating controlled gas delivery and airway clearance during emergency interventions.

This device is supplied as a reusable medical instrument, intended for use in clinical settings such as neonatal intensive care units (NICUs) or delivery rooms. It is not classified as sterile and requires proper maintenance per manufacturer guidelines. The Resuscitation Unit 105 holds an FDA 510(k) clearance (K103317) under the regulatory classification of Class II (BZR product code, regulation 868.5330). Compliance with manufacturer instructions and periodic servicing ensures safe operation.

Frequently asked questions

What clinical scenarios is the Resuscitation Unit 105 primarily designed to support during neonatal resuscitation?

The Resuscitation Unit 105 is specifically designed to assist in neonatal resuscitation by removing secretions from infant airways while delivering a precisely blended mixture of air and oxygen (adjustable from 21% to 100%) to respiratory support devices. This makes it ideal for use in neonatal intensive care units (NICUs) or delivery rooms during critical interventions where controlled gas delivery and airway clearance are essential, such as during mechanical ventilation or oxygen tent therapy.

Is the Resuscitation Unit 105 intended for single-use or reusable applications, and what maintenance is required?

The Resuscitation Unit 105 is supplied as a reusable medical instrument, meaning it is not intended for single-use. Since it is not sterile, proper cleaning, maintenance, and periodic servicing per the manufacturer’s guidelines are required to ensure safe and effective operation. Regular upkeep is critical to prevent contamination and maintain functionality in clinical settings.

How does the regulatory pathway for the Resuscitation Unit 105 differ from other anesthesia-related devices, and what does this imply for its use?

The Resuscitation Unit 105 holds an FDA 510(k) clearance under the product code BZR (Breathing Gas Mixers) and is classified as a Class II device, regulated under 21 CFR 868.5330. This classification reflects its role in blending and delivering breathing gases, which is distinct from other anesthesia-related devices. The clearance implies it has been deemed substantially equivalent to a predicate device, ensuring it meets established safety and performance standards for use in neonatal resuscitation and respiratory support.

What types of respiratory support devices can the Resuscitation Unit 105 interface with, and how does it contribute to patient care?

The Resuscitation Unit 105 is designed to interface with neonatal respiratory assist devices, including ventilators and oxygen tents, to deliver blended air and oxygen (21–100%) while simultaneously facilitating airway clearance by removing secretions. This dual functionality ensures that infants receive both precise gas therapy and mechanical suctioning during critical interventions, improving outcomes in high-risk resuscitation scenarios.

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: RESUSCITATION UNIT 105 (K103317) — FDA 510(k) | Innolitics, Model 105 Resuscitator Blender Unit P and E Type Operation Manual May ..., Operation Manual Search System | ATOM MEDICAL, Resuscitation Unit 105 510 (k) FDA Premarket Notification K103317 ATOM ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Atom Medical Corporation

Sources (1)

  • FDA 510(k) K103317 24 fields · synced Sep 18, 2026