De Novo · Granted
GrantedEchoTip Insight Portosystemic Pressure Gradient Measuring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Ireland, Ltd. · QIJ Endoscopic Transhepatic Venous Access Needle
Granted on Nov 20, 2019 as a new device type through De Novo after a 366-day review.
- Decided
- Nov 20, 2019
- Review
- 366 days
- Class
- Class II
- Product code
- QIJ
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo 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 QIJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
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.
How does its category compare?
All QIJ devicesQIJ Endoscopic Transhepatic Venous Access Needle: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · QIJ
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · QIJ
Too few QIJ 510(k)s in any year since 2007 to give a median.
Recalls per year · QIJ
No recall names QIJ since 2007.
Adverse event reports per year · QIJ
1in 2025
MAUDE reports naming product code QIJ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The EchoTip® Insight™ Portosystemic Pressure Gradient Measurement System is indicated to directly measure pressures in the hepatic and portal venous vasculatures and is used in conjunction with an ultrasound endoscope.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN180062 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN180062: EchoTip Insight Portosystemic Pressure Gradient Measuring System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN180062
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026