Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, Blood Pressure Cuff, U1885S, U1885D, U1880S, U1880D, U1886S, U1886D, Blood Pressure Cuff, U1869S, U1869D, U1889S, U1889D, U1884S, U1884D, Blood Pressure Cuff, U1710S, U1720S, U1730S,U1740S, U1750S, U1760S, Blood Pressure Cuff, U1770S, U1790s, U1710D, U1720D, U1730D, U1740D

Q: Who is the manufacturer of Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, Blood Pressure Cuff, U1885S, U1885D, U1880S, U1880D, U1886S, U1886D, Blood Pressure Cuff, U1869S, U1869D, U1889S, U1889D, U1884S, U1884D, Blood Pressure Cuff, U1710S, U1720S, U1730S,U1740S, U1750S, U1760S, Blood Pressure Cuff, U1770S, U1790s, U1710D, U1720D, U1730D, U1740D?

Jkh USA, LLC filed the 510(k) submission for Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, Blood Pressure Cuff, U1885S, U1885D, U1880S, U1880D, U1886S, U1886D, Blood Pressure Cuff, U1869S, U1869D, U1889S, U1889D, U1884S, U1884D, Blood Pressure Cuff, U1710S, U1720S, U1730S,U1740S, U1750S, U1760S, Blood Pressure Cuff, U1770S, U1790s, U1710D, U1720D, U1730D, U1740D (K203652).

Q: What is the FDA product code for Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, Blood Pressure Cuff, U1885S, U1885D, U1880S, U1880D, U1886S, U1886D, Blood Pressure Cuff, U1869S, U1869D, U1889S, U1889D, U1884S, U1884D, Blood Pressure Cuff, U1710S, U1720S, U1730S,U1740S, U1750S, U1760S, Blood Pressure Cuff, U1770S, U1790s, U1710D, U1720D, U1730D, U1740D?

DXQ. It is classified under 21 CFR 870.1120 as a Class 2 device in the Cardiovascular panel.

Q: What is the regulatory pathway for Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, Blood Pressure Cuff, U1885S, U1885D, U1880S, U1880D, U1886S, U1886D, Blood Pressure Cuff, U1869S, U1869D, U1889S, U1889D, U1884S, U1884D, Blood Pressure Cuff, U1710S, U1720S, U1730S,U1740S, U1750S, U1760S, Blood Pressure Cuff, U1770S, U1790s, U1710D, U1720D, U1730D, U1740D?

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

Q: What are the predicate devices for Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, Blood Pressure Cuff, U1885S, U1885D, U1880S, U1880D, U1886S, U1886D, Blood Pressure Cuff, U1869S, U1869D, U1889S, U1889D, U1884S, U1884D, Blood Pressure Cuff, U1710S, U1720S, U1730S,U1740S, U1750S, U1760S, Blood Pressure Cuff, U1770S, U1790s, U1710D, U1720D, U1730D, U1740D?

Unimed Blood Pressure Cuff (K112544); Unimed Disposable Blood Pressure Cuff (K120364).

Q: Who can help prepare an FDA 510(k) submission like Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, Blood Pressure Cuff, U1885S, U1885D, U1880S, U1880D, U1886S, U1886D, Blood Pressure Cuff, U1869S, U1869D, U1889S, U1889D, U1884S, U1884D, Blood Pressure Cuff, U1710S, U1720S, U1730S,U1740S, U1750S, U1760S, Blood Pressure Cuff, U1770S, U1790s, U1710D, U1720D, U1730D, U1740D?

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.

K203652 · Jkh USA, LLC · DXQ · Jan 6, 2021 · Cardiovascular

Device Facts

Record ID	K203652
Device Name	Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, Blood Pressure Cuff, U1885S, U1885D, U1880S, U1880D, U1886S, U1886D, Blood Pressure Cuff, U1869S, U1869D, U1889S, U1889D, U1884S, U1884D, Blood Pressure Cuff, U1710S, U1720S, U1730S,U1740S, U1750S, U1760S, Blood Pressure Cuff, U1770S, U1790s, U1710D, U1720D, U1730D, U1740D
Applicant	Jkh USA, LLC
Product Code	DXQ · Cardiovascular
Decision Date	Jan 6, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1120
Device Class	Class 2
Attributes	Pediatric

Intended Use

The Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressure measurement systems. The cuff is non-sterile. It is available in neonatal, pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.

Device Story

Device is an accessory for non-invasive blood pressure measurement systems; consists of inelastic sleeve with integrated inflatable bladder, tubing, and hook-and-loop closure. Wrapped around patient limb (arm or leg) to facilitate blood pressure monitoring. Operates by receiving pneumatic pressure from external measurement system; bladder inflates to occlude artery. Used in clinical settings by healthcare professionals. Output is pneumatic pressure transmission to monitor; enables blood pressure determination. Benefits include non-invasive, reliable blood pressure assessment across patient sizes.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing and comparison to identical predicate devices.

Technological Characteristics

Materials: PU synthetic leather, PVC composite nonwoven, transparent polyurethane (TPU) bladder, PVC tubing, molded nylon hook/loop. Pressure limit: 0-300mmHg. Reusable models rated for 10,000 inflations and 3,000 closures. Standards: ISO 81060-1, ISO 10993-1, ISO 10993-5, ISO 10993-10. Non-sterile.

Indications for Use

Indicated for use as an accessory with non-invasive blood pressure measurement systems in neonatal, pediatric, and adult patient populations.

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

Unimed Blood Pressure Cuff (K112544)
Unimed Disposable Blood Pressure Cuff (K120364)

Related Devices

K242623 — Disposable Blood Pressure cuff; Reusable Blood Pressure cuff · Shenzhen Medke Technology Co., Ltd. · Oct 31, 2024
K232772 — Blood Pressure Cuff (1201D1,12L2D1,1202D1,12L3D1,1203D1,1204D1,1205D1,1206D1,1207D1-1#,1207D1-2#,1207D1-3#,1207D1-4#,1207D1-5#,1201B1,12L2B1,1202B1,12L3B1,1203B1,1204B1,1205B1,1206B1,1207B1-1#,1207B1-2#,,1207B1-3#,1207B1-4#,1207B1-5#,1201W2,12L2W2,1202W2,12L3W2,1203W2,1204W2,1205W2,1206W2 and 1207W2) · Shenzhen Plinma Technology Co. , Ltd. · Nov 29, 2023
K071885 — ANTIMICROBIAL AND SINGLE-PATIENT CUFFS · Philips Medical Systems · Dec 20, 2007
K112544 — UNIMED BLOOD PRESSURE CUFF · Unimed Medical Supplies, Inc. · Nov 22, 2011
K092999 — NBP CUFF · Draeger Medical AG & Co. KG · Nov 24, 2009

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. January 6, 2021 JKH USA, LLC Bill Dai, Manager 14271 Jeffrey Rd. #246 Irvine. California 92620 # Re: K203652 Trade/Device Name: Blood Pressure Cuff Reusable Blood Pressure Cuff models: PU1883D, PU1882S, PU1882D, PU1881S, PU1881D, PU1885S, PU1885D, PU1880S, PU1880D, PU1886S, PU1886D, PU1869D, PU1889S, PU1889D, PU1884S, PU1884D. Disposable Blood Pressure Cuff models: PU1710S, PU1720S, PU1730S, PU1740S, PU1750S, PU1760S, PU1770S, PU1790S, PU1710D, PU1720D, PU1740D, PU1750D, PU1760D, PU1770D, PU1790D, PU1781S, PU1782S, PU1783S, PU1784S, PU1785S, PU1781D, PU1782D, PU1783D, PU1784D, PU1785D. Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXQ Dated: December 2, 2020 Received: December 14, 2020 # Dear Bill Dai: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. {1}------------------------------------------------ If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, for LT Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K203652 Device Name Blood Pressure Cuff Indications for Use (Describe) The Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressure measurement systems. The cuff is non-sterile. It is available in neonatal, pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |----------------------------------------------------------------------------------------------------------------------| | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary | Submitter: | Name: JKH USA, LLC Mailing Address: 14271 Jeffrey Rd. #246, Irvine, CA 92620 | |-----------------------|----------------------------------------------------------------------------------------| | Contact Person: | Name: Bill Quanqin Dai Phone Number: 909-929-9896 Email Address: Bill@jkhUSA.com | | Date Prepared: | 12/02/2020 | | Device Trade Name: | Blood Pressure Cuff | | Device Common Name: | Blood Pressure Cuff | | Classification Names: | Blood Pressure Cuff | | Regulation Number: | 21 CFR 870.1120 | | Product Code: | DXQ | | Predicate Device 1: | | | 510(k) Number: | K112544 | | Device Name: | Unimed Blood Pressure Cuff | | Manufacturer: | UNIMED MEDICAL SUPPLIES INC | | Predicate Device 2: | | | 510(k) Number: | K120364 | | Device Name: | Unimed Disposable Blood Pressure Cuff | | Manufacturer: | UNIMED MEDICAL SUPPLIES INC | #### Description of Devices: The device comprises tubing attached to an inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. The device tubing is connected to a non-invasive blood pressure measurement system. The subject device is categorized into two types of models according to its reusability. Refer to the master list of models below. Reusable Blood Pressure Cuff models: PU1883D, PU1883D, PU1882S, PU1882D, PU1881S, PU1881D, PU1885S, PU1885D, PU1880S, PU1880D, PU1886S, PU1869S, PU1869D, PU1889S, PU1889D, PU1884S, PU1884D. Disposable Blood Pressure Cuff models: PU1710S, PU1720S, PU1730S, PU1740S, PU1750S, PU1760S, PU1770S, PU1790S, PU1710D, PU1720D, PU1730D, PU1740D, PU1750D, PU1760D, PU1770D, PU1790D, PU1781S, PU1782S, PU1783S, PU1784S, PU1785S, PU1781D, PU1782D, PU1783D, PU1784D, PU1785D. #### Indications for Use: The Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressure measurement systems. The cuff is non-sterile. It is available in neonatal, pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated. {4}------------------------------------------------ # Comparison to predicate device: The subject and predicate devices are exactly the same, and there is no any difference between them. | Description | Subject Device | Predicate Device (K112544 and K120364) | |-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for use | The Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressure measurement systems. The cuff is non-sterile. It is available in neonatal, pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated. | The Unimed Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated. | | Prescription/ over-the-cou nter use | Prescription | Prescription | | Target population | Adults/Pediatrics/neonatal | Adults/Pediatrics/neonatal | | Application site | Arm or leg | Arm or leg | | Material | Reusable Cuffs: PU Synthetic Leather Reusable Cuffs: PVC composite nonwoven Bladder: Transparent Polyurethane (TPU Film) Tubing: PVC Hook: Molded Nylon Loop: Nylon | Reusable Cuffs: PU Synthetic Leather Reusable Cuffs: PVC composite nonwoven Bladder: Transparent Polyurethane (TPU Film) Tubing: PVC Hook: Molded Nylon Loop: Nylon | | Tube Configuration | One or two tube | One or two tube | | Repeated inflation | For reusable cuffs: 10,000 inflations 3,000 hook and loop closures | For reusable cuffs: 10,000 inflations 3,000 hook and loop closures | | Pressure limits | 0-300mmHg | 0-300mmHg | | Usage | Reusable and disposable | Reusable and disposable | | Sterile | Non-sterile | Non-sterile | | Standards met | ISO 81060-1 ISO 10993-1 ISO 10993-5 ISO 10993-10 | ISO 81060-1 ISO 10993-1 ISO 10993-5 ISO 10993-10 | | Table 1 Substantial Equivalence Table | | |---------------------------------------|--| |---------------------------------------|--| Non-clinical test data: {5}------------------------------------------------ The subject device meets the following the recognized standards: - ISO 81060-1 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type - ISO 10993-1 Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process - ISO 10993-5, Biological evaluation of medical devices-Part 5: Tests for In Vitro cytotoxicity - ISO 10993-10, Biological evaluation of medical devices-Part 10: Tests for irritation and delayed-type hypersensitivity The proposed device belongs to skin contact, and the contact duration is less than 30 days. Biocompatibility tests have been conducted on the proposed device, including cytotoxicity, sensitization, and skin irritation. The test results show that the proposed device has no issue of cytotoxicity, sensitization, or skin irritation. #### Clinical test data: The subject and predicate devices are exactly the same. Since the blood pressure cuffs are identical, no further clinical testing is necessary. ### Substantial Equivalence: The subject and predicate devices are exactly the same. The blood pressure cuffs are identical to the cleared version and are not modified. Therefore, the subject device is substantially equivalent to the predicate device.