SK MED M201 PLUS MIXER

K031707 · Sk Med · BZR · Aug 1, 2003 · Anesthesiology

Device Facts

• Record ID: K031707
• Device Name: SK MED M201 PLUS MIXER
• Applicant: Sk Med
• Product Code: BZR · Anesthesiology
• Decision Date: Aug 1, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5330
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The M201Plus Mixer is used to deliver a mixture of air and oxygen in conjunction with oxygen hoods, resuscitation bags, masks, and nasal cannulas. The user can adjust the oxygen percentage within a range of 21-100% and the flow rate within a range of 0-30 liters per minute. Additionally, the device monitors the air supply pressure, oxygen supply pressure, battery voltage, and output oxygen percentage.

Device Story

SK Med M201Plus Mixer; pneumatic device for blending air and oxygen. Inputs: air and oxygen supply lines. Operation: user-adjustable oxygen concentration (21-100%) and flow rate (0-30 L/min). Monitoring: air/oxygen supply pressures, battery voltage, and output oxygen percentage. Used in clinical settings; operated by healthcare professionals. Output: blended gas delivered to patient interfaces (hoods, masks, cannulas). Benefits: precise control of oxygen delivery for respiratory support.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Breathing gas mixer; 21-100% O2 concentration range; 0-30 L/min flow range. Includes integrated monitoring for supply pressures, battery status, and output concentration. Class II device (21 CFR 868.5330).

Indications for Use

Indicated for patients requiring supplemental oxygen therapy delivered via oxygen hoods, resuscitation bags, masks, or nasal cannulas. No specific age or gender restrictions provided.

Regulatory Classification

Identification

A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 1 2003

Mr. Dipak Ghosh President SK Med, Incorporated 16000 Sherman Way # 224 Van Nuys, California 91406-4057

Re: K031707

Trade/Device Name: SK Med M201 Plus Mixer Regulation Number: 21 CFR 868.5330 Regulation Name: Breathing Gas Mixer Regulatory Class: II Product Code: BZR, CCL Dated: July 23, 2003 Received: July 24, 2003

Dear Mr. Ghosh:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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## Page 2 - Mr. Ghosh

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours.

Patricio Cucurella

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Attachment 1 Indications for Use Statement

510(k) Number: K ○ 3 | 707

Device Name: SK Med M201Plus Mixer

## Indications for Use:

The M201Plus Mixer is used to deliver a mixture of air and oxygen in conjunction with oxygen hoods, resuscitation bags, masks, and nasal cannulas. The user can adjust the oxygen percentage within a range of 21-100% and the flow rate within a range of 0-30 liters per minute. Additionally, the device monitors the air supply pressure, oxygen supply pressure, battery voltage, and output oxygen percentage.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter-Use (Optional Format 1-2-96)

P. Cussenat for Vente.

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number KU3707