← Back to catalogue

Sapphire Ventilator, Non-Continuous (Respirator)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K152356

by Respironics, Inc.

Identifiers

510(k) Number
K152356 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 Sapphire is a Ventilator, Non-Continuous (Respirator) designed to assist or control patient ventilation during anesthesia or critical care procedures. It delivers controlled breaths to patients requiring temporary respiratory support, such as those undergoing surgical anesthesia or acute respiratory distress.

This device is intended for use in clinical settings, including operating rooms and intensive care units, and is classified under FDA product code BZD as a Class II device with special controls. It is supplied as a reusable medical device, with regulatory clearance granted under FDA 510(k) K152356 as substantially equivalent to a predicate device, and is governed by regulation number 868.5905. No third-party certification or additional sterility requirements are specified in the data.

Frequently asked questions

What clinical settings is the Sapphire Ventilator intended for use in, and what types of patients does it support?

The Sapphire is designed for use in clinical settings such as operating rooms and intensive care units. It provides controlled ventilation assistance or control for patients requiring temporary respiratory support during procedures like surgical anesthesia or acute respiratory distress.

Is the Sapphire Ventilator a single-use or reusable device, and what does that mean for maintenance?

The Sapphire is a reusable medical device, meaning it is intended for repeated use after proper cleaning, disinfection, and maintenance according to manufacturer guidelines. This design allows for cost-effective use in clinical environments where multiple patients may require ventilation support.

How is the Sapphire Ventilator regulated in the U.S., and what does its classification mean for healthcare providers?

The Sapphire Ventilator holds FDA clearance under the 510(k) pathway (K152356) as substantially equivalent to a predicate device, classified as a Class II medical device under product code BZD. This means it is subject to special controls and regulatory oversight to ensure safety and effectiveness, but it does not require third-party certification beyond FDA compliance.

Are there specific storage requirements or considerations for the Sapphire Ventilator?

The Sapphire is a reusable device, so storage requirements focus on maintaining cleanliness and functionality between uses. While no sterility requirements are specified in the data, it should be stored in a dry, clean environment, protected from dust and moisture, and per manufacturer instructions to ensure proper operation and longevity.

What does the advisory committee classification (Anesthesiology) indicate about the Sapphire’s intended use?

The Sapphire’s classification under the Anesthesiology advisory committee reflects its primary role in assisting or controlling ventilation during anesthesia procedures. This designation indicates the device was reviewed by experts in anesthesiology to ensure it meets clinical needs for patients undergoing surgical anesthesia or critical care where respiratory support is required.

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: K152356 FDA 510(k) - Sapphire | Respironics, Inc., PDF K152356 - Sapphire, Sapphire 510(k) K152356 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Respironics, Inc.

Sources (1)

  • FDA 510(k) K152356 24 fields · synced Sep 19, 2026