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Respire Disposable Pulmonary Resuscitator

FDA 510(k)

Class II (US FDA 510(k))

510(k) K913474

by Med-Tek Innovations, Inc.

Identifiers

510(k) Number
K913474 FDA 510(k)
FDA Product Code
BTM FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.5915 FDA 510(k)
Regulation Number
868.5915 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Respire Disposable Pulmonary Resuscitator is a manual emergency ventilator designed for manual resuscitation of patients. Classified as a Ventilator, Emergency, Manual (Resuscitator), it provides positive-pressure ventilation to support breathing in clinical emergencies.

This device is intended for single-use and is supplied sterile. It is regulated under FDA 510(k) clearance (K913474) and falls under the BTM product code. The device is intended for use in clinical settings where immediate respiratory support is required, adhering to FDA guidelines for Class II medical devices.

Frequently asked questions

What is the primary use case for the Respire Disposable Pulmonary Resuscitator in clinical settings?

The Respire Disposable Pulmonary Resuscitator is designed exclusively for manual resuscitation to provide positive-pressure ventilation in emergency situations where immediate respiratory support is required. It is intended for use in clinical settings, such as hospitals or emergency rooms, to assist patients who are unable to breathe on their own during critical moments.

Is the Respire Disposable Pulmonary Resuscitator intended for single-use or repeated use?

The Respire Disposable Pulmonary Resuscitator is explicitly intended for single-use only. This design ensures sterility and reduces the risk of cross-contamination between patients, which is critical in emergency resuscitation scenarios.

How is the Respire Disposable Pulmonary Resuscitator supplied, and what does that mean for its handling?

The device is supplied sterile, meaning it is pre-sterilized and packaged to maintain that sterility until use. This allows clinicians to immediately deploy the device in emergencies without additional sterilization steps, ensuring readiness and safety for critical patient care.

What regulatory pathway was followed for the FDA clearance of the Respire Disposable Pulmonary Resuscitator?

The Respire Disposable Pulmonary Resuscitator received FDA clearance through a 510(k) submission, specifically under the Traditional clearance type. It was determined to be substantially equivalent to a legally marketed device and was reviewed by the Anesthesiology Device Advisory Committee. The clearance number is K913474, and it falls under the BTM product code.

Are there multiple models or sizes available for the Respire Disposable Pulmonary Resuscitator?

The provided data lists multiple FEI numbers (e.g., 3013557562, 3034669683), which typically correspond to different lot or batch identifiers rather than distinct models or sizes. However, no explicit details about varying sizes, models, or configurations are provided in the data. For precise sizing or model-specific inquiries, direct contact with Med-Tek Innovations, Inc. would be necessary.

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: RESPIRE DISPOSABLE PULMONARY RESUSCITATOR (K913474) — FDA 510(k ..., RESPIRE DISPOSABLE PULMONARY RESUSCITATOR 510(k)… - FDA.report, MED-TEK INNOVATIONS, INC. FDA Filings - FDA.report, Med-Tek Innovations, Inc. · DeviceClearance

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Med-Tek Innovations, Inc.

Sources (1)

  • FDA 510(k) K913474 24 fields · synced Sep 19, 2026