YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff
Device Facts
| Record ID | K260747 |
|---|---|
| Device Name | YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff |
| Applicant | Nihon Kohden Corporation |
| Product Code | DXQ · Cardiovascular |
| Decision Date | May 6, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1120 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The NIBP Cuff (YP-710T series) is an accessory used in conjunction with non-invasive blood pressure measurement systems. The cuff is non-sterile and reusable. It is available in pediatric and adult sizes. The device is intended for use by qualified medical personnel and within a medical facility. The Disposable Cuff (YP-840T series) is an accessory used in conjunction with non-invasive blood pressure measurement systems. The cuff is non-sterile and disposable (single-use). It is available in pediatric and adult sizes. The device is intended for use by qualified medical personnel and within a medical facility.
Device Story
YP-710T (reusable) and YP-840T (disposable) series blood pressure cuffs; applied to patient limbs; connected to Nihon Kohden host NIBP monitoring systems via dual-tube air hose; host device supplies air pressure for inflation; used by qualified medical personnel in medical facilities; provides non-invasive blood pressure measurement; design includes legacy twist-type or IEC 80369-5 compliant small-bore connectors; facilitates clinical blood pressure monitoring.
Clinical Evidence
Bench testing only. Evaluation included biocompatibility (ISO 10993-1, -5, -10, -12, -23), air leakage (limit <4mmHg/min), pressure range (0-300 mmHg), and small-bore connector compliance (IEC 80369-5).
Technological Characteristics
Materials: Polyester, Polyvinyl Chloride (PVC). Sensing: Pneumatic inflation via host device. Connectivity: Dual-tube air hose with legacy twist or IEC 80369-5 small-bore connectors. Standards: ISO 10993 (biocompatibility), IEC 80601-2-30 (automated sphygmomanometers), ISO 81060-1 (non-automated sphygmomanometers), IEC 80369-5 (connectors).
Indications for Use
Indicated for use as an accessory with non-invasive blood pressure measurement systems in pediatric and adult patient populations within medical facilities by qualified medical personnel.
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
- SOFT-CUF (K120125)
Submission Summary (Full Text)
{0}
FDA U.S. FOOD & DRUG ADMINISTRATION
May 6, 2026
Nihon Kohden Corporation
% Charlemagne Chua
Senior Manager, Regulatory Affairs
Nihon Kohden America, LLC
15353 Barranca Pkwy.
Irvine, California 92618
Re: K260747
Trade/Device Name: YP-710T Series NIBP Cuff; YP-840T Series Disposable Cuff
Regulation Number: 21 CFR 870.1120
Regulation Name: Blood Pressure Cuff
Regulatory Class: Class II
Product Code: DXQ
Dated: March 6, 2026
Received: March 6, 2026
Dear Charlemagne Chua:
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 (the 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 available 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.
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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
{1}
K260747 - Charlemagne Chua
Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
{2}
K260747 - Charlemagne Chua
Page 3
assistance/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,
STEPHEN C. BROWNING -S
LCDR Stephen Browning
Assistant Director
Division of Cardiac Electrophysiology,
Diagnostics and Monitoring Devices
Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
{3}
FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services (301) 443-6740
EF
| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K260747 | |
| Device Name YP-710T Series NIBP Cuff; YP-840T Series Disposable Cuff | |
| Indications for Use (Describe) YP-710T Series NIBP Cuff The NIBP Cuff (YP-710T series) is an accessory used in conjunction with non-invasive blood pressure measurement systems. The cuff is non-sterile and reusable. It is available in pediatric and adult sizes. The device is intended for use by qualified medical personnel and within a medical facility. YP-840T Series Disposable Cuff The Disposable Cuff (YP-840T series) is an accessory used in conjunction with non-invasive blood pressure measurement systems. The cuff is non-sterile and disposable (single-use). It is available in pediatric and adult sizes. The device is intended for use by qualified medical personnel and within a medical facility. | |
| 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." | |
{4}
Traditional 510(k) – YP-710T Series, YP-840T Series
510(K) Summary
# 510(k) SUMMARY
## Administrative Information
**Sponsor:**
Nihon Kohden Corporation
1-31-4 Nishiochiai, Shinjuku-Ku
Tokyo, Japan 161-8560
FDA Est. Registration: 9611252
**Submitter:**
Nihon Kohden America, LLC
15353 Barranca Parkway
Irvine, CA 92618
FDA Est. Registration: 2080783
**Primary Correspondent /U.S. Agent:**
Charlemagne Chua
Senior Manager, Regulatory Affairs
15353 Barranca Parkway
Irvine, CA 92618
Office Phone: (949) 268-0868
Email: charlemgne_chua@nihonkohden.com
**Secondary Correspondent:**
Deborah Im
Senior Specialist, Regulatory Affairs
15353 Barranca Parkway
Irvine, CA 92618
Office Phone: (949) 268-7708
Email: deborah_im@nihonkohden.com
06 MAR 2026
Page 1 of 10
K260747
{5}
Traditional 510(k) – YP-710T Series, YP-840T Series
510(K) Summary
# Subject Device Information
Submission Type: Traditional 510(k)
Common Device Name: Blood Pressure Cuff
Regulation Medical Specialty: Cardiovascular
Classification Panel: Cardiovascular
Product Codes: DXQ
Premarket Review: Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Regulation Number: 870.1120
Classification: Class II
Decision Type: 510(k)
Proprietary Name: YP-710T series NIBP Cuff
YP-840T series Disposable Cuff
Reason for 510(k) Submission: Modification to an Existing Device and Introduction of New Device
Original 510(k) / Predicate: SOFT-CUF Blood Pressure Cuff (K120125)
Predicate Manufacturer: GE Medical Systems Information Technologies, Inc.
Submission Date: March 6, 2026
06 MAR 2026
Page 2 of 10
K260747
{6}
Traditional 510(k) – YP-710T Series, YP-840T Series
510(K) Summary
# 1. PRODUCT DESCRIPTION
The YP-710T and YP-840T series are blood pressure cuffs that are applied to the patient's upper or lower limb and connected to a Nihon Kohden host device to measure blood pressure non-invasively. The cuffs are inflated using air pressure supplied from the connected host device.
The YP-710T series is a reusable cuff, intended for repeated use with multiple patients. The YP-840T series is a disposable cuff, intended for single use only. Each series comprises six (6) models based on cuff size. In addition, each model is available with two (2) connector options: A locking connector (twist type) or a small-bore connector compliant with IEC 80369-5 requirements. These are distinguished using different catalog numbers.
# 2. INDICATION FOR USE / INTENDED USE
## YP-710T Series
Intended Use: The NIBP Cuff (YP-710T series) is used to measure non-invasive blood pressure.
Indication for Use: The NIBP Cuff (YP-710T series) is an accessory used in conjunction with non-invasive blood pressure measurement systems. The cuff is non-sterile and reusable. It is available in pediatric and adult sizes. The device is intended for use by qualified medical personnel and within a medical facility.
## YP-840T Series
Intended Use: The Disposable Cuff (YP-840T series) is used to measure non-invasive blood pressure.
Indication for Use: The Disposable Cuff (YP-840T series) is an accessory used in conjunction with non-invasive blood pressure measurement systems. The cuff is non-sterile and disposable (single-use). It is available in pediatric and adult sizes. The device is intended for use by qualified medical personnel and within a medical facility.
# 3. SUBMISSION SCOPE
Nihon Kohden (NK) is requesting market clearance for a modified Nihon Kohden device, the modification to an existing device and introduction of new device. The modification is replaced the current twist type connector with a small bore connector (compliant with IEC80369-5).
06 MAR 2026
Page 3 of 10
K260747
{7}
Traditional 510(k) – YP-710T Series, YP-840T Series
510(K) Summary
# 4. COMPARISON WITH THE PREDICATE / REFERENCE DEVICE
## 4.1 Subject Device Information
Table 1 provides the regulation and classification for the subject device.
Table 1 Regulatory Information on YP-710T Series and YP-840T Series
| Device | Regulation | Product Code | Device Classification | Classification |
| --- | --- | --- | --- | --- |
| YP-710T Series | §870.1120 | DXQ | Blood pressure cuff. | Class II |
| YP-840T Series | §870.1120 | DXQ | Blood pressure cuff. | Class II |
## 4.2 Predicate / Reference Device Information
Table 2 lists the basic information about the predicate devices and reference device including 510(k) number, device name, 510(k) holder, and clearance date. Regulatory information used for comparison is provided in Table 3
Table 2 Predicate Device General Information
| Device | Predicate/Reference Device General Information | | | |
| --- | --- | --- | --- | --- |
| | 510(k) Number | Device Name | 510(k) Holder | Clearance Date |
| SOFT-CUF | K120125 | SOFT-CUF | GE Medical Systems Information Technologies, Inc. | October 3, 2012 |
Table 3 Predicate Device Regulatory Information
| Device | Regulation | Product Code | Device Classification | Classification |
| --- | --- | --- | --- | --- |
| SOFT-CUF | §870.1120 | DXQ | Blood Pressure Cuff | Class II |
06 MAR 2026
Page 4 of 10
K260747
{8}
Traditional 510(k) – YP-710T Series, YP-840T Series
510(K) Summary
# 4.3 Comparison Table
Table 4 Comparison Table of the YP-710T and YP-840T Series and Predicate Device
| Description | Predicate Device SOFT-CUF Blood Pressure Cuff K120125 | Subject Device YP-710T series YP-840T series | Comparison |
| --- | --- | --- | --- |
| Manufacturer | GE Medical Systems Information Technologies, Inc. | Nihon Kohden Corporation | Different |
| Product Code | DXQ | DXQ | Same |
| Indications for Use | GE CRITIKON blood pressure cuffs are accessories used in conjunction with noninvasive blood pressure (NIBP) measurement systems. SOFT-CUF and CLASSIC-CUF cuffs and inflation systems are non-sterile and limited reuse (may be single-patient use or optional limited reuse). They are available in neonatal, pediatric and adult sizes. The devices are not designed, sold or intended for use except as indicated. | YP-710T series The NIBP Cuff (YP-710T series) is an accessory used in conjunction with non-invasive blood pressure measurement systems. The cuff is non-sterile and reusable. It is available in pediatric and adult sizes. The device is intended for use by qualified medical personnel and within a medical facility. YP-840T series The Disposable Cuff (YP-840T series) is an accessory used in conjunction with non-invasive blood pressure measurement systems. The cuff is non-sterile and disposable (single-use). It is available in pediatric and adult sizes. The device is intended for use by qualified medical personnel and within a medical facility. | Different |
| Use Characteristics | Non-sterile, single patient use or limited reuse | YP-710T series Non-sterile, reprocessed for reuse YP-840T series Non-sterile, disposable (single-use) | Different |
| Population | Adult, pediatric, neonatal | Adult and pediatric | Different |
| Intended Use | Indirect measurement of blood pressure | YP-710T series The NIBP Cuff (YP-710T series) is used to measure non-invasive blood pressure. YP-840T series | Same |
06 MAR 2026
Page 5 of 10
K260747
{9}
Traditional 510(k) – YP-710T Series, YP-840T Series
510(K) Summary
| Description | Predicate Device SOFT-CUF Blood Pressure Cuff K120125 | Subject Device YP-710T series YP-840T series | Comparison |
| --- | --- | --- | --- |
| | | The Disposable Cuff (YP-840T series) is used to measure non-invasive blood pressure. | |
| Environmental Specifications | | | |
| Operating Conditions | Temperature 0° C to 46° C Relative Humidity 15% to 90% humidity, non-condensing | Temperature 10 to 40°C (50 to 104°F) Relative Humidity 15 to 85% (non-condensing) | Different |
| Storage Conditions | Temperature -20° C to 55° C Relative Humidity 0% to 95% humidity, non-condensing | YP-710T Series Temperature -20 to +60°C (-4 to +140°F) Relative Humidity 10 to 95% (non-condensing) YP-840T Series Temperature -20 to +65°C (-4 to +149°F) Relative Humidity 10 to 95% (non-condensing) | Different |
| Physical Specifications | | | |
| Limb Circumference (Ranges in cm) | Neonatal #1 (3-6) Neonatal #2 (4-8) Neonatal #3 (6-11) Neonatal #4 (7-13) Neonatal #5 (8-15) Infant (8-13) Child (12-19) Child Long (12-19) Small Adult (17-25) Small Adult Long (17-25) Adult (23-33) Adult Long (23-33) Large Adult (31-40) Large Adult Long (31-40) Thigh (38-50) | Infant (8-13) Child (13-18) Small Adult (18-23) Adult (23-33) Large Adult (33-45) Thigh (45-55) | Different |
| Bladder Size | Various bladder sizes for neonate, pediatric and adult populations | Various bladder sizes for pediatric and adult populations | Different |
| Cuff Connector Configurations | Adult and Pediatric 2-Tube configuration: • Screw Connector • Sub-Miniature Connector • Mated Subminiature Connector | • Legacy locking connector (twist type) • Small-bore connector | Different |
06 MAR 2026
Page 6 of 10
K260747
{10}
Traditional 510(k) – YP-710T Series, YP-840T Series
510(K) Summary
| Description | Predicate Device SOFT-CUF Blood Pressure Cuff K120125 | Subject Device YP-710T series YP-840T series | Comparison |
| --- | --- | --- | --- |
| | • Dual CLICK-IT (branded as “DINACLICK”) Connector Adult and Pediatric 1-Tube configuration: • Bayonet Connector • Screw • Sub-Miniature Connector Neonatal • 1-Tube and 2-Tube Male Slip Luer Taper • 1-Tube and 2-Tube SNAP-IT (branded as “NeoSnap”) Connectors | | |
| **Materials** | | | |
| Cuff / Integrated Bladder / Ink | SOFT-CUF: Laminate of polyester / polyvinyl chloride/ SOFT-CUF: Zephyron-Ion Solvent Based | YP-710T Series Cuff: Polyester Tube: Polyvinyl Chloride YP-840T Series Cuff: Laminate of polyester and polyvinyl chloride Tube: Polyvinyl Chloride | Different |
| **Compatibility** | | | |
| Device | Single / dual tubes, adaptors and bulb / valve assemblies for use with manual and automated sphygmomanometers. | Connect to the host device with automated NIBP monitoring capability (automated sphygmomanometer) via dual-tube air hose. | Different |
| **Performance Specifications** | | | |
| Leak Rate | Maximum allowable pressure loss rate is 0.6 sccm (standard cubic cm per minute) | Not specified | Different |
| Air Leakage | Less than 4mmHg/min | Less than 4mmHg/min | Same |
| Pressure Range | 0-300 mmHg | 0-300 mmHg | Same |
| **Standards Compliance** | | | |
| Automated/Manual Sphygmomanometers | SP10:2002/A1:2003/A2:2006 | IEC 80601-2-30:2018 (applicable sections) ISO 81060-1:2007 (applicable sections) | Different |
| | EN 1060-1:1995/A1:2002/A2:2009 (applicable sections) EN 1060-2:1995/C1:2002/A1:2009 (applicable sections) | | |
06 MAR 2026
Page 7 of 10
K260747
{11}
Traditional 510(k) – YP-710T Series, YP-840T Series
510(K) Summary
| Description | Predicate Device SOFT-CUF Blood Pressure Cuff K120125 | Subject Device YP-710T series YP-840T series | Comparison |
| --- | --- | --- | --- |
| | IEC 80601-2-30:2009 (applicable sections) ISO 81060-1:2007 (applicable sections) | | |
| Biocompatibility Standard Compliance | Cuff fabric, ink, loop evaluated per ISO10993-1:2009 • Irritation • Sensitization • Cytotoxicity | ISO10993-1:2018 Irritation • Sensitization • Cytotoxicity | Different |
# 5. PERFORMANCE
## 5.1 Summary of Non-Clinical Performance Testing
Nihon Kohden conducted non-clinical bench performance testing as part of the design verification and validation activities. The YP-710T series (NIBP Cuffs) and YP-840T series (Disposable Cuffs) were evaluated for reprocessing & shelf-life, biocompatibility, and usability performance. The same test methods and specifications were used as for the predicate device, establishing equivalency with the predicate devices. These tests were performed according to the international and FDA-recognized consensus standards listed in Table 7.
Table 7 Applied Standards and Guidance List for the YP-710T Series (NIBP Cuffs) and YP-840T Series (Disposable Cuffs)
| Rec. No. | Standard | Description |
| --- | --- | --- |
| 5-125 | ISO 14971:2019 | Medical devices - Application of risk management to medical devices |
| 2-258 | ISO 10993-1:2018 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process |
| 2-245 | ISO 10993-5:2009 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity |
| 2-296 | ISO 10993-10:2021 | Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization |
| 2-291 | ISO 10993-23: 2021 | Biological evaluation of medical devices - Part 23: Tests for irritation |
| 2-289 | ISO 10993-12: 2021 | Biological evaluation of medical devices - Part 12: Sample preparation and reference materials |
| 3-123 | IEC 80601-2-30: 2018 | Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers Partial compliance |
| 3-96 | ISO 81060-1: 2007 | Non-invasive sphygmomanometers Part 1: Requirements and test methods for non-automated measurement type |
06 MAR 2026
Page 8 of 10
K260747
{12}
Traditional 510(k) – YP-710T Series, YP-840T Series
510(K) Summary
| Rec. No. | Standard | Description |
| --- | --- | --- |
| | | Partial compliance |
| 5-107 | IEC 80369-5: 2016 | Small-bore connectors for liquids and gases in healthcare applications Part 5: Connectors for limb cuff inflation applications It only applies to the YP-710T and YP-840T series with a small-bore connector. |
| 14-575 | ASTM F1980-21 | Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices |
# 6. SUBSTANTIAL EQUIVALENCE DISCUSSION
The comparison of the YP-710T series (NIBP Cuffs) and YP-840T series (Disposable Cuffs) to its predicate device (SOFT-CUF, K120125 and the discussion of the key aspects are presented in the following sections.
# 6.1 Discussion of Intended Use
In comparing the Intended Use between the YP-710T series (NIBP Cuffs) and YP-840T series (Disposable Cuffs) and its predicate device, the Intended Use are the same.
# 6.2 Discussion of Indications for Use
In comparing the Indications for Use between the YP-710T series (NIBP Cuffs) and YP-840T series (Disposable Cuffs) and its predicate device, both are accessories noninvasive blood pressure (NIBP) measuring systems.
# 6.3 Discussion for Technological Characteristics
The YP-710T series (NIBP Cuffs) and YP-840T series (Disposable Cuffs) and its predicate device have similar technological characteristics.
# 6.4 Discussion for Design Characteristics
There are slight differences between the YP-710T series (NIBP Cuffs) and YP-840T series (Disposable Cuffs) and the predicate as referenced. The differences are based on design changes to accommodate new design improvement and to ensure compliance with current applicable standards. The changes have been evaluated to ensure there is no impact on the safety and effectiveness of the YP-710T series (NIBP Cuffs) and YP-840T series (Disposable Cuffs).
06 MAR 2026
Page 9 of 10
K260747
{13}
Traditional 510(k) – YP-710T Series, YP-840T Series
510(K) Summary
## 6.5 Discussion for Compatible Devices
The YP-710T series (NIBP Cuffs) and YP-840T series (Disposable Cuffs) and predicate device require the device to be connected to noninvasive blood pressure (NIBP) measurement systems. The subject device will be used with more Nihon Kohden noninvasive blood pressure (NIBP) measurement systems that have received 510(k) clearance.
## 6.6 Discussion for Performance Specifications
The YP-710T series (NIBP Cuffs) and YP-840T series (Disposable Cuffs) has been compared and evaluated using the same performance methods and testing criteria as the predicate.
## 7. CONCLUSION
The results of the substantial equivalence assessment, taken together with non-clinical bench testing and validation demonstrate that the YP-710T series (NIBP Cuffs) and YP-840T series (Disposable Cuffs) do not raise concerns regarding their safety and effectiveness compared to their predicate device and operates in accordance with claimed indications for use. YP-710T series (NIBP Cuffs) and YP-840T series (Disposable Cuffs) are substantially equivalent to the predicate device.
06 MAR 2026
Page 10 of 10
K260747
