Arterial Pressure Monitoring Set/Tray
FDA 510(k) K254278 · Spectrum Vascular
510(k) numberK254278
Submission
- Device name
- Arterial Pressure Monitoring Set/Tray
- Applicant
- Spectrum Vascular
White Plains, NY, US - Received
- December 30, 2025
- Decision date
- March 25, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
Other 510(k)s with product code DQO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261455 | Arterial Pressure Monitoring Set/TrayDQO · Traditional | Spectrum Vascular | 06/26/2026SE |
| K252702 | Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF…DQO · Traditional | Bioptimal International Pte. , Ltd. | 05/28/2026SE |
| K250751 | DualView CatheterDQO · Traditional | Terumo Corporation | 07/17/2025SE |
| K242966 | Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterDQO · Traditional | Gentuity, LLC | 01/31/2025SE |
| K242420 | pNOVUS 21 MicrocatheterDQO · Traditional | Phenox, Ltd. | 11/12/2024SE |
| K233268 | Impress Angiographic CatheterDQO · Special | Merit Medical Systems, Inc. | 05/22/2024SE |
| K233975 | Zoom 6F Insert CathetersDQO · Traditional | Imperative Care, Inc. | 04/02/2024SE |
| K232536 | Soldier MicrocatheterDQO · Traditional | Embolx, Inc. | 02/23/2024SE |
| K232573 | INFINITI Ambi Angiographic CatheterDQO · Traditional | Cordis US Corp | 11/21/2023SE |
| K230620 | Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging CatheterDQO · Traditional | Gentuity, LLC | 08/08/2023SE |
More from Gentuity, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K260165 | Unimpregnated Central Venous CatheterFOZ · Traditional | 08/10/2026SE |
| K261455 | Arterial Pressure Monitoring Set/TrayDQO · Traditional | 06/26/2026SE |
| K252373 | BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with…LJS · Traditional | 12/16/2025SE |
| K250724 | Intraosseous Infusion NeedlesFMI · Traditional | 07/30/2025SE |
| K241115 | SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV…FOZ · Traditional | 11/27/2024SE |
Questions and answers
When was Arterial Pressure Monitoring Set/Tray cleared by the FDA?
Arterial Pressure Monitoring Set/Tray (K254278) received a 510(k) decision of Substantially Equivalent on March 25, 2026, 85 days after the submission was received.
What is the product code of K254278?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.