KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105

K021634 · King Systems Corp. · CAE · Jan 9, 2003 · Anesthesiology

Device Facts

• Record ID: K021634
• Device Name: KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105
• Applicant: King Systems Corp.
• Product Code: CAE · Anesthesiology
• Decision Date: Jan 9, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5110
• Device Class: Class 1
• Attributes: Therapeutic

Indications for Use

The KING LT oropharyngeal airway is intended for use in adult patients for controlled ventilation during anesthesia for procedures of short duration, when the patient is considered to have a low risk of aspiration of stomach contents.

Device Story

The King LT is an oropharyngeal airway device designed to facilitate controlled ventilation. It is used by clinicians in clinical settings during anesthesia for short-duration procedures. The device is inserted into the patient's airway to maintain a patent airway and provide ventilation. It is intended for patients identified as low risk for aspiration. The device functions as a mechanical airway adjunct to support respiratory management during medical procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Oropharyngeal airway device; mechanical design; intended for adult use; classified as Class I under 21 CFR 868.5110.

Indications for Use

Indicated for adult patients requiring controlled ventilation during short-duration anesthesia procedures, specifically for patients at low risk of aspiration of stomach contents.

Regulatory Classification

Identification

An oropharyngeal airway is a device inserted into a patient's pharynx through the mouth to provide a patent airway.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 0 9 2003

Mr. Tom McGrail Director, R & D King Systems Corporation 15011 Herriman Boulevard Noblesville, Indiana 46060

Re: K021634

Trade/Device Name: King LTTM Regulation Number: 868.5110 Regulation Name: Oropharyngeal Airway Regulatory Class: I Product Code: CAE Dated: December 30, 2002 Received: January 3, 2003

Dear Mr. McGrail:

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.

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

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Page 2 - Mr. McGrail

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]. Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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 yours,

Timot 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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510(k) Number (if known): K021634

Device Name: KING LTTM

Indications for Use:

The KING LT oropharyngeal airway is intended for use in adult patients for controlled ventilation during anesthesia for procedures of short duration, when the patient is considered to have a low risk of aspiration of stomach contents.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k)

(Optional Format 3-10-98)

(Posted July 1, 1998)

Back to the Indications for Use Page

Prescription Use (Per 21 CFR 801.109)

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