Arterial Pressure Monitoring Set/Tray

K254278 · Spectrum Vascular · DQO · Mar 25, 2026 · Cardiovascular

Device Facts

• Record ID: K254278
• Device Name: Arterial Pressure Monitoring Set/Tray
• Applicant: Spectrum Vascular
• Product Code: DQO · Cardiovascular
• Decision Date: Mar 25, 2026
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1200
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Arterial Pressure Monitoring Set/Tray is intended for arterial blood pressure monitoring and blood sampling in adult and pediatric patients. - 2.5 French catheters are intended for patients from birth and older. - 3.0 and 4.0 French catheters are intended for patients aged 1 year and older. - 5.0 French catheters are intended for patients aged 12 years and older.

Device Story

Arterial pressure monitoring set/tray; includes pressure monitoring catheter, wire guide, entry access needle, syringe. Catheter inserted percutaneously via Seldinger technique into radial artery, femoral artery, or distal aorta. Used for continuous arterial blood pressure monitoring and blood sampling. Operated by clinicians in clinical settings. Output is direct pressure signal to external monitor; enables real-time hemodynamic assessment and blood gas/lab analysis. Benefits include accurate, continuous monitoring of critically ill patients.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including biocompatibility testing per ISO 10993 and ink legibility performance testing.

Technological Characteristics

Materials: Polyethylene, Ethylene-Vinyl Acetate, Polyurethane, Nylon, Stainless Steel. Single lumen catheter with straight tip. Sterilization: EtO (SAL 10^-6). Packaging: Tray with Tyvek lidstock. No electrical components or software.

Indications for Use

Indicated for arterial blood pressure monitoring and blood sampling in adult and pediatric patients. 2.5F catheters for neonates and older; 3.0F and 4.0F for patients aged 1 year and older; 5.0F for patients aged 12 years and older.

Regulatory Classification

Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Predicate Devices

• Arterial Pressure Monitoring Set/Tray (K180846)
• Arterial Pressure Monitoring Set/Tray (K180792)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

March 25, 2026

Spectrum Vascular
Sharon Klugewicz
Senior VP, Quality and Regulatory Affairs
50 Main St.
Suite 1000
White Plains, New York 10606

Re: K254278
Trade/Device Name: Arterial Pressure Monitoring Set/Tray
Regulation Number: 21 CFR 870.1200
Regulation Name: Diagnostic Intravascular Catheter
Regulatory Class: Class II
Product Code: DQO
Dated: February 24, 2026
Received: February 24, 2026

Dear Sharon Klugewicz:

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

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K254278 - Sharon Klugewicz
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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-

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K254278 - Sharon Klugewicz
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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).

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

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FORM FDA 3881 (6/20)
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: 06/30/2023 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K254278 | |
| Device Name Arterial Pressure Monitoring Set/Tray | |
| Indications for Use (Describe) The Arterial Pressure Monitoring Set/Tray is intended for arterial blood pressure monitoring and blood sampling in adult and pediatric patients. - 2.5 French catheters are intended for patients from birth and older. - 3.0 and 4.0 French catheters are intended for patients aged 1 year and older. - 5.0 French catheters are intended for patients aged 12 years and older. | |
| 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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510(k) Summary
Spectrum Vascular
K254278

# 1. SUBMITTER INFORMATION

Applicant: Spectrum Vascular
Contact: Ms. Sharon Klugewicz
Phone: [phone]
Email: [e-mail]
Address: 50 Main Street, Suite 1000
White Plains, NY 10606

# 2. CORRESPONDENT INFORMATION

Contact: Ms. Sharon Klugewicz
Title: Senior VP, Quality and Regulatory Affairs
Firm: Spectrum Vascular
50 Main Street, Suite 1000
White Plains, NY 10606
Phone: [phone]
Email: [e-mail]

# 3. DATE PREPARED: MARCH 24, 2026

# 4. DEVICE INFORMATION

Device Name: Arterial Pressure Monitoring Set/Tray
Common Name: Diagnostic intravascular catheter
Regulation Number: 21 CFR 870.1200
Regulation Name: Diagnostic intravascular catheter
Product Code: DQO
Regulatory Class: Class II

# 5. PREDICATE DEVICE INFORMATION

Primary Predicate Device Name: Arterial Pressure Monitoring Set/Tray
510(k) Number: K180846
Manufacturer: Cook Incorporated

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510(k) Summary

Spectrum Vascular

K254278

Secondary Predicate Device Name: Arterial Pressure Monitoring Set/Tray

510(k) Number: K180792

Manufacturer: Cook Incorporated

# 6. DEVICE DESCRIPTION

The Arterial Pressure Monitoring Set/Tray is intended to be used for arterial pressure monitoring and blood sampling. The pressure monitoring catheter is inserted into the vasculature using the Seldinger technique. Based on the device length, the subject device may gain access via the radial artery, femoral artery, or distal aorta.

The Arterial Pressure Monitoring Set/Tray is comprised of a pressure monitoring catheter, wire guide, entry access needle, and syringe. The Arterial Pressure Monitoring Set/Tray is supplied sterile and intended for one-time use.

# 7. INDICATIONS FOR USE

The Arterial Pressure Monitoring Set/Tray is intended for arterial blood pressure monitoring and blood sampling in adult and pediatric patients.

- 2.5 French catheters are intended for patients from birth and older.
- 3.0 and 4.0 French catheters are intended for patients aged 1 year and older.
- 5.0 French catheters are intended for patients aged 12 years and older.

# 8. COMPARISON OF INTENDED USE AND TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Other than the change in ink as noted in Table 1, the subject device is identical to the primary and secondary predicate devices.

Table 1: Technological Comparison to Predicate Devices

| | Primary Predicate Device (K180846) | Secondary Predicate Device (K180792) | Subject Device |
| --- | --- | --- | --- |
| Regulation | 21 CFR 870.1200 | 21 CFR 870.1200 | 21 CFR 870.1200 |
| Product Code | DQO | DQO | DQO |
| Classification | Class II | Class II | Class II |
| Catheter Insertion Method | Percutaneously via Seldinger technique | Percutaneously via Seldinger technique | Percutaneously via Seldinger technique |
| Catheter Shaft Material | Polyethylene Ethylene-Vinyl Acetate Polyurethane Ink Marking: UVA Ink (Color #1 Black) | Nylon Ink Marking: UVA Ink (Color #1 Black) | Polyethylene Ethylene-Vinyl Acetate Polyurethane Ink Marking: UVA Ink (TPC 980 Black Ink) |

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510(k) Summary
Spectrum Vascular
K254278

| | Primary Predicate Device (K180846) | Secondary Predicate Device (K180792) | Subject Device |
| --- | --- | --- | --- |
| Catheter Hub Material | Polyethylene
Polyurethane | Nylon | Polyethylene
Polyurethane
Nylon |
| Catheter Outer Diameter | 2.5, 3.0, 4.0 French | 5.0 French | 2.5, 3.0, 4.0, 5.0 French |
| Catheter Length | 2.5, 4.0, 5.0, 6.0, 8.0, 12.0 cm | 15 cm | 2.5, 4.0, 5.0, 6.0, 8.0, 12.0, 15 cm |
| Catheter Lumen Design | Single lumen | Single lumen | Single lumen |
| Catheter Distal End | Straight tip | Straight tip | Straight tip |
| Dilator Shaft Material | Polyethylene | N/A | Polyethylene |
| Wire Guide Material | Stainless Steel | Stainless Steel | Stainless Steel |
| Wire Guide Diameter | 0.015, 0.018, 0.021, 0.035 inch | 0.035 inch | 0.015, 0.018, 0.021, 0.035 inch |
| Packaging | Tray w/ Tyvek Lidstock | Tray w/ Tyvek Lidstock | Tray w/ Tyvek Lidstock |
| Single Use? | Yes | Yes | Yes |
| Sterilization Method | EtO | EtO | EtO |
| Sterility Assurance Level | 10^{-6} | 10^{-6} | 10^{-6} |

## 9. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING

### Biocompatibility Testing

The catheter of the subject device is identical to the Arterial Pressure Monitoring Set/Tray cleared in K180846 and K180792 with the exclusion of the marker ink. Additional biocompatibility testing on the subject device was conducted in accordance with the ISO 10993 series.

### Electrical Safety

Not applicable. The subject device contains no electrical components, generates no electrical emissions, and uses no electrical energy of any type.

### Electromagnetic Compatibility (EMC)

Not applicable. The subject device contains no electrical components, generates no electrical emissions, and uses no electrical energy of any type.

### Software

Not applicable. The subject device contains no software.

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510(k) Summary
Spectrum Vascular
K254278

## Performance Testing

An additional ink legibility performance test was conducted to demonstrate that the device meets its design requirements and performs as intended.

## 10. CONCLUSION

The results of the performance testing described above demonstrate that the Arterial Pressure Monitoring Set/Tray perform equivalently as compared to the primary and secondary predicate devices and supports a determination of substantial equivalence.

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