Who is the manufacturer of RESCUE BREATHER?

International Safety, Inc. filed the 510(k) submission for RESCUE BREATHER (K955520).

What is the FDA product code for RESCUE BREATHER?

CBP. It is classified under 21 CFR 868.5870 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for RESCUE BREATHER?

510(k) clearance (submission type: Traditional).

What are the predicate devices for RESCUE BREATHER?

Res-Cue Key™ and Life Key™ by Ambu, Inc. (K900260).

Who can help prepare an FDA 510(k) submission like RESCUE BREATHER?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

RESCUE BREATHER

K955520 · International Safety, Inc. · CBP · Oct 8, 1996 · Anesthesiology

Device Facts

Record ID	K955520
Device Name	RESCUE BREATHER
Applicant	International Safety, Inc.
Product Code	CBP · Anesthesiology
Decision Date	Oct 8, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5870
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Intended Use

The Rescue Breather is intended to separate the patient and the rescuer during cardiopulmonary resuscitation (CPR) on adults and children. It is a single use device and is not sold sterile.

Device Story

Rescue Breather is a flat, 6" x 11" CPR mask with integral ear loops; provides physical barrier between rescuer and patient skin/mucous membranes; features central one-way valve to direct airflow to patient; single-use; non-sterile; used by rescuers during CPR; prevents direct contact with oral secretions; facilitates safe ventilation.

Clinical Evidence

Bench testing only. Device meets all specifications relevant to its features per ASTM Standard F 920-93.

Technological Characteristics

Sheet-type mask; materials: surgical glove quality natural latex and nylon; integral ear loops; central one-way valve; non-sterile; dimensions 6" x 11".

Indications for Use

Indicated for use by rescuers performing cardiopulmonary resuscitation (CPR) on adult and pediatric patients to provide a barrier between the rescuer and the patient's skin, mucous membranes, and oral secretions.

Regulatory Classification

Identification

A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.

Predicate Devices

Res-Cue Key™ and Life Key™ by Ambu, Inc. (K900260)

Related Devices

K112126 — GENUINE FIRST AID CPR MASK · Genuine First Aid, LLC · Dec 1, 2011
K102299 — CPR FACE MASK · Genuine First Aid, LLC · Mar 18, 2011
K953414 — CPR MICROMASK WITH OXYGEN INLET · Plasco, Inc. · Mar 20, 1996
K192285 — CPR Face Shield · Firstar Healthcare Company Limited (Guangzhou) · Nov 25, 2020
K052743 — DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921 · Dynarex Corp. · Dec 22, 2005

Submission Summary (Full Text)

{0} Oct-04-96 07:04A colvin/bovard 541-345-5431 P.02 # INTERNATIONAL SAFETY INC. K955520 510(K) SUMMARY MANUFACTURING DIVISION P.O. BOX 20961 KEIZER, OR. 97307-0961 OCT -8 1996 800-733-9007 503-463-1445 Contact person: Gordon Jackson Date summary prepared: October 4, 1996 Device name: Proprietary name: Rescue Breather™ Common or usual name: Cardiopulmonary Resuscitation (CPR) mask. Classification name: Nonrebreathing valve, Class II, 21 CFR 868.5870. Legally marketed device for substantial equivalence comparison: Res-Cue Key™ and Life Key™ by Ambu, Inc. cleared under K900260. Description of the device: The device is a flat sheet measuring 6" by 11" which has integral ear loops to hold it in position during use. The mask provides separation between the skin, mucous membranes and oral secretions of the patient and the rescuer. There is a one-way valve in the middle of the mask which directs breathing flow to the patient. Intended Use of Device: The Rescue Breather is intended to separate the patient and the rescuer during cardiopulmonary resuscitation (CPR) on adults and children. It is a single use device and is not sold sterile. The intended use of the Res-Cue Key/Life Key is identical. Technological Characteristics: The Rescue Breather and the Res-Cue Key/Life Key are both sheet-type masks with ear loops for attachment to the patient. Both have one-way valves in the middle of the mask. Neither device has any portion which extends into the patient's mouth. The two devices are composed of different materials. The Rescue Breather is composed of surgical glove quality natural latex and nylon. The Res-Cue Key and Life Key are composed of high and low density polymers. Performance Data Testing delineated in the ASTM Standard F 920-93 has been conducted. The device meets all specifications relevant to its features.