510(k) · Cleared
ClearedCook Pressure Monitoring Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook, Inc. · DQO Catheter, Intravascular, Diagnostic
Cleared on Mar 16, 2001 after a 234-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 14 later devices descend from it.
- Decided
- Mar 16, 2001
- Review
- 234 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 3 citing it directly.
- This deviceK002254 Cook Pressure Monitoring CatheterCook, Inc. · 2001
- Descendant · cites it directly · 9 of its ownK151821 ER-REBOA CatheterPryor Medical Devices, Inc. · 2015
- Descendant · 2 generations on · 8 of its ownK170411 ER-REBOA CatheterPrytime Medical Devices, Inc. · 2017
- Descendant · 3 generations on · 4 of its ownK172790 ER-REBOA CatheterPrytime Medical Devices, Inc. · 2017
- Descendant · cites it directly · 2 of its ownK180846 Arterial Pressure Monitoring Set/TrayCook Incorporated · 2018 · Recalled
- Descendant · cites it directly · 2 of its ownK180792 Arterial Pressure Monitoring Set/TrayCook Incorporated · 2018
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K151821ER-REBOA CatheterPryor Medical Devices, Inc. · 2015 · cites it directly9descendants
- K170411ER-REBOA CatheterPrytime Medical Devices, Inc. · 2017 · 2 generations on8descendants
- K172790ER-REBOA CatheterPrytime Medical Devices, Inc. · 2017 · 3 generations on4descendants
- K180846Arterial Pressure Monitoring Set/TrayCook Incorporated · 2018 · cites it directly2descendants
- K180792Arterial Pressure Monitoring Set/TrayCook Incorporated · 2018 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002254 | Cook Pressure Monitoring Catheter | Cook, Inc. | 2001 | — |
| +1 | K151821 | ER-REBOA Catheter | Pryor Medical Devices, Inc. | 2015 | — |
| +2 | K170411 | ER-REBOA Catheter | Prytime Medical Devices, Inc. | 2017 | — |
| +3 | K172790 | ER-REBOA Catheter | Prytime Medical Devices, Inc. | 2017 | — |
| +1 | K180846 | Arterial Pressure Monitoring Set/Tray | Cook Incorporated | 2018 | 1 |
| +1 | K180792 | Arterial Pressure Monitoring Set/Tray | Cook Incorporated | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (14)
See all 143 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K151821 (Pryor Medical Devices, Inc., 2015) has gone furthest, with 9 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.
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) | — |
https://510kreport.com/device/K002254 · printed Nov 5, 2026
Cite this page
510(k) Report. “K002254: Cook Pressure Monitoring Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K002254
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026