Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)

K253070 · Medline Industries, LP · DXC · Nov 20, 2025 · Cardiovascular

Device Facts

• Record ID: K253070
• Device Name: Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)
• Applicant: Medline Industries, LP
• Product Code: DXC · Cardiovascular
• Decision Date: Nov 20, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Namic Radial Arm Band is indicated to apply compression in order to achieve hemostasis while allowing the user to maintain patency of the radial artery after a transradial procedure (patent hemostasis).

Device Story

Tourniquet-style device for post-transradial catheterization hemostasis; consists of wristband with hook-and-loop fasteners, two compression balloons, support plate, input valve, and inflation device. Physician secures band around patient's wrist; connects inflation device to input valve; manually inflates balloons to apply pressure to access site. Pressure adjusted by physician via inflation device to achieve hemostasis while maintaining radial artery patency. Disposable, single-use device used in clinical settings.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench performance testing and biocompatibility evaluation per ISO 10993-1 for surface-contacting devices with breached skin (<24h duration). Bench testing included visual inspection, dimensional analysis, air leakage, axial load, shear/peel strength, and packaging integrity tests.

Technological Characteristics

Materials: PVC (wristband, balloons, tubing), Polycarbonate (support plate, input valve), Nylon (fastener), Polypropylene (inflator). Principle: Pneumatic compression. Form factor: Wristband with two balloons. Connectivity: None. Sterilization: 2X ETO. Standards: ISO 80369-7, ASTM D5169-98, ASTM D5170-98, ASTM F1886, ASTM F1929, ASTM F88, ASTM F2096.

Indications for Use

Indicated for adult patients requiring compression to achieve hemostasis while maintaining radial artery patency following transradial procedures.

Regulatory Classification

Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

Predicate Devices

• TR BAND Radial Compression Device (K213531)

Submission Summary (Full Text)

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FDA U.S. FOOD &amp; DRUG ADMINISTRATION

November 20, 2025

Medline Industries, LP.
Payal Solanki
Regulatory Affairs Specialist
Three Lakes Drive
Northfield, Illinois 60093

Re: K253070
Trade/Device Name: Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)
Regulation Number: 21 CFR 870.4450
Regulation Name: Vascular Clamp
Regulatory Class: Class II
Product Code: DXC
Dated: September 22, 2025
Received: September 23, 2025

Dear Payal Solanki:

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.

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"

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(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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 systems (QS) regulation (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-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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K253070 - Payal Solanki
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Sincerely,

Katherine N. Trivedi -S
Digitally signed by
Katherine N. Trivedi -S
Date: 2025.11.20 17:31:32
-07'00'

Katherine Trivedi
Assistant Director
DHT2B: Division of Circulatory Support, Structural, and Vascular Devices
OHT2: Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K253070 | |
| Device Name Namic Radial Arm Band | |
| Indications for Use (Describe) The Namic Radial Arm Band is indicated to apply compression in order to achieve hemostasis while allowing the user to maintain patency of the radial artery after a transradial procedure (patent hemostasis). | |
| 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 [e-mail] | |
| "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." | |

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MEDLINE

# SECTION 08

# 510(k) SUMMARY

[According to 21 CFR 807.92]

# 510(k) Summary Preparation Date

September 22, 2025

# Submitter/Applicant

Medline Industries, LP.

Three Lakes Drive

Northfield, IL 60093

# Contact Person

Name: Payal Solanki, Regulatory Affairs Specialist

Email: [e-mail]

Phone: [phone]

# Type of 510(k) Submission

Traditional

# Subject Device

Trade Name: Namic Radial Arm Band

Common Name: Radial compression device

Classification Name: Clamp, Vascular

Product Code: DXC

Review Panel: Cardiovascular

Regulatory Class: Class II

Regulation Number: 21 CFR 870.4450

# Predicate Device

K213531 - TR BAND Radial Compression Device

# Device Description

The Namic Radial Arm Band is a tourniquet-style device consisting of a soft wristband with a secure hook and loop adjustable fastener on each end, two compression balloons, a support plate, flexible tubing with the input valve, and an inflation device. The device is offered in two lengths, 23 cm and 26 cm.

The use of the Namic Radial Arm Band begins after the transradial catheterization procedure is concluded and as the introducer sheath is gradually withdrawn from the patient. The wristband is placed around the patient's wrist with the adjustable hook and loop fastener. Once the Radial Arm Band is secured in place,

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the inflation device is connected via the input valve and tubing. The inflation device is used to apply pressure to the patient's access site. Both radial compression balloons (RCB) are filled with air at the same time to allow for efficient compression for hemostasis. The volume of air can be increased or decreased using the inflation device, thus allowing the physician to adjust the pressure in the Radial Arm Band. The Namic Radial Arm Band is a disposable, single use only device. The Namic Radial Arm Band is for use with the adult population.

## Intended Use / Indications for Use

The Namic Radial Arm Band is indicated to apply compression in order to achieve hemostasis while allowing the user to maintain patency of the radial artery after a transradial procedure (patent hemostasis).

## Comparison of Technological Characteristics

The subject device, Namic Radial Arm Band is substantially equivalent in function and intended use to the legally marketed device, TR BAND Radial Compression Device cleared in K213531. The comparative table below (Table 1) offers details pointing to similarities and differences.

Table 1: Subject and Predicate Device Comparison Table

| Feature | Subject Device | Predicate Device | Comparison Analysis |
| --- | --- | --- | --- |
| Product Name | Namic Radial Arm Band | TR BAND Radial Compression Device | N/A |
| 510(k) Number | TBD | K213531 | N/A |
| 510(k) Owner | Medline Industries, LP. | Terumo Medical Corporation | N/A |
| Product Code | DXC | DXC | Identical |
| Regulation No. | 21 CFR 870.4450 | 21 CFR 870.4450 | Identical |
| Regulation Description | Clamp, Vascular | Clamp, Vascular | Identical |
| Review Panel | Cardiovascular | Cardiovascular | Identical |
| Intended Use / Indications for Use | The Namic Radial Arm Band is indicated to apply compression in order to achieve hemostasis while allowing the user to maintain patency of the radial artery after a transradial procedure (patent hemostasis). | The TR Band® is a compression device indicated to apply compression in order to achieve hemostasis while allowing the user to maintain patency of the radial artery after a transradial procedure (patent hemostasis). | Identical |
| Principle of Operation | Operated manually. Pneumatic compression balloons are filled to apply pressure to the access site. | Operated manually. Pneumatic compression balloons are filled to apply pressure to the access site. | Identical |
| Design Features | A tourniquet style device consisting of a wristband with a secure hook and | A tourniquet style device consisting | Identical |

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| Feature | Subject Device | Predicate Device | Comparison Analysis |
| --- | --- | --- | --- |
| | loop adjustable fastener on each end, two compression balloons, a support plate, inflation device input valve (injection port), and an inflation device (inflator). | of a belt (wristband) with hook and loop adjustable fastener on each end, two compression balloons, a support plate and an injection port. The device also contains a TR Band Inflator. | |
| Materials | Wristband – Polyvinyl chloride | Wristband (Belt) – Polyvinyl chloride | Identical |
| | Compression Balloons – Polyvinyl chloride | Compression Balloons – Polyvinyl chloride | Identical |
| | Flexible Tubing – Polyvinyl chloride | Flexible Tubing – Polyvinyl chloride | Identical |
| | Support Plate – Polycarbonate | Support Plate – Polycarbonate | Identical |
| | Hook and Loop Securement (Adjustable fastener) – Nylon | Hook and Loop Securement (Adjustable fastener) – Nylon | Identical |
| | Inflation Device Input Valve (Air Injection Port with Valve) – Polycarbonate; no colorant | Inflation Device Input Valve (Air Injection Port with Valve) – ABS Resin; colorant | Different |
| | Inflation Device (Inflator) – Polypropylene | Inflation Device (Inflator) – Polypropylene | Identical |
| Device Specifications (Length) | Regular band - 23 cm | Regular - 24 cm | Similar |
| | Large band - 26 cm | Large band - 29 cm | Similar |
| Sterile vs. Non-Sterile | Sterile | Sterile | Identical |
| Single Use vs. Reusable | Single Use | Single Use | Identical |
| Disposable vs. Non-Disposable | Disposable | Disposable | Identical |
| Sterilization | 2X ETO | 2X ETO | Identical |

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| Feature | Subject Device | Predicate Device | Comparison Analysis |
| --- | --- | --- | --- |
| Prescription vs OTC | Prescription | Prescription | Identical |

Both the subject and the predicate device have identical intended use, principle of operation, design features, and overall technological characteristics, and similar lengths. Both devices are prescription use, sterile, disposable and single use. The subject device is different from the predicate in one minor way: the material for the Inflation Device Input Valve (Air Injection Port with Valve) component.

Evidence of the safety and effectiveness of the subject device has been established via non-clinical and biocompatibility testing. Particularly, for minor material differences that exist as noted above, the biocompatibility testing demonstrates that such differences do not raise different questions of safety or effectiveness.

Therefore, it can be concluded that the subject device is substantially equivalent to the predicate device.

## Summary of Non-Clinical Testing

## Performance Testing (Bench)

The following non-clinical testing was conducted on the Namic Radial Arm Band to demonstrate substantial equivalence to the predicate.

- Visual Inspection - Internal test method
- Dimensional Analysis - Internal test method
- Sub-Atmospheric Air Leakage - ISO 80369-7:2021
- Resistance to Separation from Axial Load - ISO 80369-7:2021
- Resistance to Separation from Unscrewing - ISO 80369-7:2021
- Resistance to Overriding - ISO 80369-7:2021
- Shear Strength - ASTM D5169-98 (2021)
- Peel Strength - ASTM D5170-98 (2021)
- Air Leakage - Internal test method
- Tubing Disconnection Strength - Internal test method
- Packaging Visual Inspection - ASTM F1886/ASTM F1886M-16
- Dye Penetration - ASTM F1929-23
- Seal Strength - ASTM F88/F88M-23
- Bubble Leak Test - ASTM F2096-11 (2019)

## Biocompatibility Testing

The biological evaluation for the Namic Radial Arm Band was conducted in accordance with FDA guidance document, "Use of International Standard ISO 10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" and ISO 10993-1:2018, Biological Evaluation of the Medical

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Devices – Part 1: Evaluation of Testing within a Risk Management Process. In accordance with ISO 10993-1, the materials of the Namic Radial Arm Band are categorized as a surface contacting device with breached skin for limited (&lt;24h) duration. As such, the following biological endpoints were evaluated:

- Physical and Chemical Information
- Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic Toxicity
- Material Mediated Pyrogenicity

## Summary of Clinical Testing

Not applicable.

## Conclusion

Based on the above, the data supports that any differences in technological characteristics do not raise new questions of safety or effectiveness. The Namic Radial Arm Band is substantially equivalent to the predicate device.

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