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BabyCare NEO2 Oxygen Concentration Controller

FDA 510(k)

Class II (US FDA 510(k))

510(k) K943797

by Bpr Medical, Ltd.

Identifiers

510(k) Number
K943797 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 BabyCare Neo2 Oxygen Concentration Controller is a Mixer, Breathing Gases, Anesthesia Inhalation device designed to regulate and blend oxygen concentrations for medical use. It ensures precise delivery of oxygen mixtures, critical for controlled ventilation and anesthesia applications in pediatric and neonatal care settings.

This device is intended for single-use in clinical environments, adhering to FDA 510(k) clearance (K943797) under regulation 868.5330. Supplied sterile and classified as Class II, it is regulated under the Anesthesiology specialty and requires proper storage to maintain sterility. The product code BZR identifies this specific model.

Frequently asked questions

Is the BabyCare Neo2 Oxygen Concentration Controller designed for reuse in clinical settings, or is it intended for single-use only?

The BabyCare Neo2 Oxygen Concentration Controller is explicitly designed for single-use in clinical environments. This is confirmed by the manufacturer’s description, which states it adheres to single-use standards while maintaining sterility upon supply.

What medical specialties or settings is this device primarily intended for, and why?

This device is classified under the Anesthesiology specialty and is intended for controlled ventilation and anesthesia applications in pediatric and neonatal care. The regulatory filing under product code BZR and the device’s role in blending precise oxygen concentrations align with critical needs in these high-precision environments.

How should the BabyCare Neo2 Oxygen Concentration Controller be stored to ensure sterility and functionality?

Since the device is supplied sterile, it must be stored in a way that preserves sterility—typically in its original packaging, away from moisture, extreme temperatures, or direct sunlight. The manufacturer’s instructions (not provided here) would detail exact storage conditions, but the key requirement is maintaining a sterile barrier until first use.

What regulatory pathway was followed for FDA clearance of this device, and what does that mean for buyers?

The BabyCare Neo2 received FDA 510(k) clearance (K943797) under the Traditional 510(k) pathway, with a decision of Substantially Equivalent (SESE) to a predicate device. This means the FDA determined it meets the same safety and performance standards as an existing, legally marketed device in the same category (Mixer, Breathing Gases, Anesthesia Inhalation). Buyers can rely on this clearance as evidence of regulatory compliance for use in U.S. clinical settings.

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: Babycare Neo2 Oxygen Concentration Controller, BABYCARE NEO2 OXYGEN CONCENTRATION CONTROLLER 510 (k)… - FDA.report, api.fda.gov, BPR MEDICAL LIMITED FDA Filings - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bpr Medical, Ltd.

Sources (1)

  • FDA 510(k) K943797 24 fields · synced Sep 19, 2026