510(k) · Cleared
ClearedArterial Pressure Monitoring Set/Tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectrum Vascular · DQO Catheter, Intravascular, Diagnostic
Cleared on Mar 25, 2026 as substantially equivalent to K180846 (Cook Incorporated, 2018) and 1 other predicate after an 85-day review. Its family tree reaches back 2 generations to 2001. 1 later device descends from it.
- Decided
- Mar 25, 2026
- Review
- 85 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K002254 (2001). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK002254 Cook Pressure Monitoring CatheterCook, Inc. · 2001
- 1 generation backK180792 Arterial Pressure Monitoring Set/TrayCook Incorporated · 2018
- This deviceK254278 Arterial Pressure Monitoring Set/TraySpectrum Vascular · 2026
- Descendant · cites it directly · 0 of its ownK261455 Arterial Pressure Monitoring Set/TraySpectrum Vascular · 2026
Most influential descendants
Showing 1 of 1 · See all- K261455Arterial Pressure Monitoring Set/TraySpectrum Vascular · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002254 | Cook Pressure Monitoring Catheter | Cook, Inc. | 2001 | — |
| −1 | K180792 | Arterial Pressure Monitoring Set/Tray | Cook Incorporated | 2018 | — |
| 0 (this device) | K254278 | Arterial Pressure Monitoring Set/Tray | Spectrum Vascular | 2026 | — |
| +1 | K261455 | Arterial Pressure Monitoring Set/Tray | Spectrum Vascular | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DQO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DQO device
- #1 K261455 Arterial Pressure Monitoring Set/Trayscore 12.2 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K180846 | Arterial Pressure Monitoring Set/TraySummary page 5…E INFORMATION Primary Predicate Device Name: Arterial Pressure Monitoring Set/Tray 510(k) Number: K180846 Manufacturer: Cook Incorporated… | 2018 |
| * | K180792 | Arterial Pressure Monitoring Set/TraySummary page 6…K254278 Secondary Predicate Device Name: Arterial Pressure Monitoring Set/Tray 510(k) Number: K180792 Manufacturer: Cook Incorporated 6. DEVICE DESCRIPTION The Arterial Pr… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261455 | Arterial Pressure Monitoring Set/Tray | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 17.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K261455 (Spectrum Vascular, 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · DQO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQO
148in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQO
1in 2023
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · DQO
656in 2025
MAUDE reports naming product code DQO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | 106 | 14 | 564 |
| 2008 | 3 | 80 | 4 | 726 |
| 2009 | 8 | 58 | 7 | 933 |
| 2010 | 7 | 137 | 11 | 556 |
| 2011 | 6 | 74 | 7 | 625 |
| 2012 | 15 | 94 | 2 | 532 |
| 2013 | 2 | — | 1 | 753 |
| 2014 | 3 | 109 | 0 | 601 |
| 2015 | 10 | 209 | 1 (1) | 628 |
| 2016 | 4 | 89 | 2 (1) | 614 |
| 2017 | 10 | 176 | 1 | 873 |
| 2018 | 10 | 234 | 2 | 777 |
| 2019 | 6 | 113 | 71 | 386 |
| 2020 | 3 | 30 | 4 (4) | 312 |
| 2021 | 1 | — | 0 | 338 |
| 2022 | 4 | 181 | 1 | 379 |
| 2023 | 4 | 73 | 1 (1) | 391 |
| 2024 | 4 | 148 | 0 | 511 |
| 2025 | 2 | — | 0 | 656 |
| 2026 | 3 | 85 | 24 (4) | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254278 · printed Nov 4, 2026
Cite this page
510(k) Report. “K254278: Arterial Pressure Monitoring Set/Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K254278
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026