POLYURETHANE BLOOD PRESSURE CUFFS

K041689 · D. E. Hokanson, Inc. · DXQ · Aug 6, 2004 · Cardiovascular

Device Facts

• Record ID: K041689
• Device Name: POLYURETHANE BLOOD PRESSURE CUFFS
• Applicant: D. E. Hokanson, Inc.
• Product Code: DXQ · Cardiovascular
• Decision Date: Aug 6, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1120
• Device Class: Class 2

Intended Use

Hokanson Digit and Penile cuffs are intended to measure blood pressure in small peripheral body parts of small diameter of the limb or digit being measured. The length of the cuff, in the case of these devices, is long enough to completely encircle the object being measured. The usage is the same as the predicate device which has been manufactured by our company since 1973.

Device Story

Hokanson Blood Pressure Digit and Penile Cuffs are pneumatic cuffs designed for blood pressure measurement in small-diameter limbs or digits. The device consists of a cuff sized to fully encircle the target anatomy. Operation involves manual or automated inflation/deflation consistent with standard blood pressure cuff usage. Used in clinical or home settings to obtain blood pressure readings; output is a pressure measurement used by clinicians or patients to assess vascular status. Benefits include accurate blood pressure monitoring in anatomical areas where standard-sized cuffs are inappropriate.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Pneumatic blood pressure cuffs; dimensions sized for small-diameter limbs/digits; non-electronic; non-sterile; manual or automated inflation/deflation mechanism.

Indications for Use

Indicated for measuring blood pressure in small peripheral body parts (digits and penile) of small diameter.

Regulatory Classification

Identification

A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.

Predicate Devices

• Hokanson Digit and Penile cuffs (manufactured since 1973)

Submission Summary (Full Text)

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Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, composed of three curved lines, representing the department's mission of protecting the health of all Americans and providing essential human services. The bird is positioned to the right of a circular seal that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 6 2004

D.E Hokanson, Inc. c/o Mr. D. Eugene Hokanson President 12840 N E 21st Place Bellevue. WA 98005

Re: K041689

Trade Name: Hokanson Blood Pressure Digit and Penile Cuffs Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: II (two) Product Code: DXQ Dated: July 14, 2004 Received: July 19, 2004

Dear Mr. Hokanson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nevers formed your becament the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of the enactment date of the Medical Device Amendments, or 10 conninered proc to may 20, 1978, 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 r ou may, ifere, whiless 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. D. Eugene Hokanson

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease of devilode that i Drivination that your device complies with other requirements of the Act that I Dr has intatutes and regulations administered by other Federal agencies. You must or any I 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 Or K 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. product in allow you to begin marketing your device as described in your Section 510(k) rremarket notification. The FDA finding of substantial equivalence of your device to a legally premated predicated. " " 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 if you desire 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 other general michinal 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.

Neil R.P. Ogden

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K041689

Device Name: Hokanson Blood Pressure Digit and Penile cuffs

Indications For Use:

Hokanson Digit and Penile cuffs are intended to measure blood pressure in small peripheral body Proxamoon Digit and I characy, the width of a blood pressure cuff should be approximately parts of small adiameter of the limb or digit being measured. The length of the cuff, in the case of these devices, is long enough to completely encircle the object being measured. The usage is the same as the predicate device which has been manufactured by our company since 1973.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) Number K041689