Arterial Pressure Monitoring Set/Tray
Device Facts
| Record ID | K261455 |
|---|---|
| Device Name | Arterial Pressure Monitoring Set/Tray |
| Applicant | Spectrum Vascular |
| Product Code | DQO · Cardiovascular |
| Decision Date | Jun 26, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1200 |
| Device Class | Class 2 |
| Attributes | Pediatric |
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.
Device Story
Arterial Pressure Monitoring Set/Tray facilitates arterial blood pressure monitoring and blood sampling. Device components include pressure monitoring catheter, wire guide, entry access needle, and syringe. Clinician inserts catheter into radial artery, femoral artery, or distal aorta using Seldinger technique. Device is sterile, single-use, and non-electrical. Output is direct arterial pressure signal transmitted to external monitoring equipment. Clinical benefit includes accurate, real-time hemodynamic monitoring and access for blood sampling.
Clinical Evidence
No clinical data. Bench testing only, specifically Ethylene Oxide Sterilization Performance Qualification to validate changes in sterilization cycle parameters.
Technological Characteristics
Catheter materials: Polyethylene, Ethylene-Vinyl Acetate, Polyurethane, Nylon. Wire guide: Stainless steel. Single lumen, straight tip. Sizes: 2.5F to 5.0F. Sterilization: Ethylene Oxide (EtO) to 10^-6 SAL. 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 birth and older; 3.0F and 4.0F for 1 year and older; 5.0F for 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 (K254278)
Reference Devices
- BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology (K252373)
- BioFlo PICC with ENDEXO Technology and PASV Valve Technology (K252373)
- BioFlo PICC with ENDEXO Technology (K252373)
- BioFlo Midline Catheter (K252373)
- Xcela Power Injectable PICC (K252373)
- Xcela PICC with PASV Valve Technology (K252373)
- Xcela Hybrid PICC with PASV Valve Technology (K252373)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
June 26, 2026
Spectrum Vascular
Sharon Klugewicz
Sr. VP Quality & Regulatory Affairs
50 Main St.
Suite 1000
White Plains, New York 10606
Re: K261455
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: May 1, 2026
Received: May 1, 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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K261455 - 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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K261455 - Sharon Klugewicz
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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,
**HETAL B. ODOBASIC -S**
for
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
# Indications for Use
510(k) Number (if known)
K261455
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.
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FORM FDA 3881 (6/20)
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PSC Publishing Services (301) 443-6740 EF
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510(k) Summary
Spectrum Vascular
K261455
# **1. SUBMITTER INFORMATION**
Applicant: Spectrum Vascular
Contact: Ms. Sharon Klugewicz
Phone: 516-425-4446
Email: sklugewicz@spectrumvascular.com
Address: 50 Main Street, Suite 1000 White
Plains, NY 10606
# **2. CORRESPONDENT INFORMATION**
Contact: Ms. Sharon Klugewicz
Title: Sr. VP, Quality & Regulatory Affairs
Firm: Spectrum Vascular
50 Main Street, Suite 1000
White Plains, NY 10606
Phone: 516-425-4446
Email: sklugewicz@spectrumvascular.com
# **3. DATE PREPARED: JUNE 25, 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: K254278
Manufacturer: Spectrum Vascular
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510(k) Summary
Spectrum Vascular
K261455
| Reference Device Name: | BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology |
| --- | --- |
| 510(k) Number: | K252373 |
| Manufacturer: | Spectrum Vascular |
## 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
Table 1 contains the technological comparison of the subject device to the primary predicate device.
Table 1: Technological Comparison to Predicate Devices
| | Predicate Device (K254278) | Subject Device |
| --- | --- | --- |
| Regulation | 21 CFR 870.1200 | 21 CFR 870.1200 |
| Product Code | DQO | DQO |
| Classification | Class II | Class II |
| Catheter Insertion Method | Percutaneously via Seldinger technique | Percutaneously via Seldinger technique |
| Catheter Shaft Material | Polyethylene | Polyethylene |
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510(k) Summary
Spectrum Vascular
K261455
| | Predicate Device (K254278) | Subject Device |
| --- | --- | --- |
| | Ethylene-Vinyl Acetate Polyurethane Nylon | Ethylene-Vinyl Acetate Polyurethane Nylon |
| Catheter Hub Material | Polyethylene Polyurethane Nylon | Polyethylene Polyurethane Nylon |
| Catheter Outer Diameter | 2.5, 3.0, 4.0, 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, 15.0 cm | 2.5, 4.0, 5.0, 6.0, 8.0, 12.0, 15.0 cm |
| Catheter Lumen Design | Single lumen | Single lumen |
| Catheter Distal End | Straight tip | Straight tip |
| Wire Guide Material | Stainless Steel | Stainless Steel |
| Wire Guide Diameter | 0.015, 0.018, 0.021, 0.035 inch | 0.015, 0.018, 0.021, 0.035 inch |
| Packaging | Tray w/ Tyvek Lidstock | Tray w/ Tyvek Lidstock |
| Single Use? | Yes | Yes |
| Sterilization Method | EtO | EtO |
| Sterility Assurance Level | 10^{-6} | 10^{-6} |
## 8.1 DISCUSSION OF SIMILARITIES AND DIFFERENCES
Other than the change in the sterilization location and sterilization cycle parameters, the subject device is identical to the predicate device. There are no changes to catheter design or materials from the predicate device. The differences in sterilization location and parameters have been validated to achieve the same sterility assurance level of 10$^{-6}$ with acceptable EO and ECH residuals and thus does not impact either the safety or the efficacy of the subject devices.
## 9. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING
### Biocompatibility Testing
The medical devices in their final finished form are identical to the predicate device (K254278) in formulation, processing, sterilization method and geometry. No other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents).
The subject device is sterilized using the same ethylene oxide (EtO) method as the predicate device, with a reduced EtO gas concentration. This represents a less aggressive exposure condition than the predicate's validated cycle. Because the predicate's biocompatibility testing was conducted under the higher EtO concentration, that testing represents the worst-case residual scenario and remains applicable to the subject device. No additional biocompatibility testing was conducted.
### Electrical Safety
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510(k) Summary
Spectrum Vascular
K261455
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.
#### **Performance Testing**
The following performance testing was conducted to validate changes to the sterilization cycle parameters:
- Ethylene Oxide Sterilization Performance Qualification
### **10. CONCLUSION**
The results of the performance testing described above demonstrate that the Arterial Pressure Monitoring Set/Tray performs equivalently to the predicate device. These results support a determination of substantial equivalence and demonstrate that the subject device is as safe and effective as the predicate device.
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