510(k) · Cleared
ClearedIntegra Jarit Heparin Cannulas, Injectors, and Needles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra LifeSciences Corporation · DQR Cannula, Catheter
Cleared on Oct 28, 2013 as substantially equivalent to K030788 (Geister Medizin Technik GmbH, 2003) after a 161-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Oct 28, 2013
- Review
- 161 days
- Class
- Class II
- Product code
- DQR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K030788 (2003). No later device cites it as a predicate yet.
- Root · 1 generation backK030788 Kamar Annulus Dilator + Sizer; Garrett, Cooley, and Debakey Vessel…Geister Medizin Technik GmbH · 2003
- This deviceK131446 Integra Jarit Heparin Cannulas, Injectors, and NeedlesIntegra LifeSciences Corporation · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K030788 | Kamar Annulus Dilator + Sizer; Garrett, Cooley, and Debakey Vessel Dilators | Geister Medizin Technik GmbH | 2003 | — |
| 0 (this device) | K131446 | Integra Jarit Heparin Cannulas, Injectors, and Needles | Integra LifeSciences Corporation | 2013 | — |
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 DQR? 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
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K030788 | Kamar Annulus Dilator + Sizer; Garrett, Cooley, and Debakey Vessel DilatorsSummary page 2…Pilling Co. Preamendment Stoney Heparin Injector Pilling Co. Preamendment Heparin Flushing Needle V. Mueller K030788 DeBakey Vessel Dilator Geister Medizintechnik GmbH There are no differences in technology, materials… | 2003 |
| * | — | DeBakey Heparin Cannula Named without a submission number | |
| * | — | Stoney Heparin Injector Named without a submission number | |
| * | — | Heparin Flushing Needle Named without a submission number |
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.
What does this lineage say?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K030788.
How does its category compare?
All DQR devicesDQR Cannula, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · DQR
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · DQR
Too few DQR 510(k)s in any year since 2007 to give a median.
Recalls per year · DQR
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQR
6in 2025
MAUDE reports naming product code DQR, 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 | 17 |
| 2008 | 1 | — | 0 | 8 |
| 2009 | 0 | — | 0 | 27 |
| 2010 | 0 | — | 0 | 24 |
| 2011 | 0 | — | 0 | 7 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 1 | — | 0 | 6 |
| 2014 | 0 | — | 0 | 8 |
| 2015 | 0 | — | 0 | 40 |
| 2016 | 0 | — | 0 | 75 |
| 2017 | 0 | — | 0 | 29 |
| 2018 | 0 | — | 0 | 17 |
| 2019 | 0 | — | 0 | 16 |
| 2020 | 0 | — | 1 | 4 |
| 2021 | 0 | — | 0 | 11 |
| 2022 | 0 | — | 0 | 27 |
| 2023 | 0 | — | 0 | 36 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Integra® Jarit® Heparin Cannulas, Injectors, and Needles are used in conjunction with various syringe sizes (not supplied by Integra®) for flushing, irrigation and solution injection into a vessel or cavity during vascular, bypass or other cardiovascular surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131446 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131446: Integra Jarit Heparin Cannulas, Injectors, and Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131446
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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