510(k) · Cleared
ClearedJostra Arterial Perfusion Cannulae, Model a...
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jostra AG · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cleared on Nov 6, 2001 after an 85-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Nov 6, 2001
- Review
- 85 days
- Class
- Class II
- Product code
- DWF
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK012617 Jostra Arterial Perfusion Cannulae, Model a...Jostra AG · 2001
- Descendant · cites it directly · 0 of its ownK023251 Pediatric Arterial CannulaPolystan A/S · 2002 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K023251Pediatric Arterial CannulaPolystan A/S · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012617 | Jostra Arterial Perfusion Cannulae, Model a... | Jostra AG | 2001 | — |
| +1 | K023251 | Pediatric Arterial Cannula | Polystan A/S | 2002 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 DWF? 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 DWF device
- #1 K251258 MC2™ Two-Stage Venous Cannula; MC2X™…score 14.6 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | — | Medtronic DLP Pediatric Arterial Cannulae Named without a submission number |
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 |
|---|---|---|---|
| K023251 | Pediatric Arterial Cannula | 2002 | 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?
- Of its descendants, K023251 (Polystan A/S, 2002) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DWF devicesDWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DWF
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DWF
89in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DWF
4in 2024
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · DWF
1,020in 2025
MAUDE reports naming product code DWF, 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 | 2 | — | 25 | 121 |
| 2008 | 6 | 95 | 25 | 126 |
| 2009 | 8 | 148 | 21 | 99 |
| 2010 | 3 | 62 | 26 | 197 |
| 2011 | 5 | 85 | 13 | 212 |
| 2012 | 10 | 110 | 37 | 233 |
| 2013 | 9 | 110 | 14 (1) | 238 |
| 2014 | 14 | 110 | 6 | 325 |
| 2015 | 9 | 46 | 3 (1) | 218 |
| 2016 | 3 | 32 | 3 | 144 |
| 2017 | 5 | 127 | 2 (1) | 101 |
| 2018 | 5 | 30 | 10 | 118 |
| 2019 | 3 | 120 | 2 | 179 |
| 2020 | 3 | 30 | 0 | 142 |
| 2021 | 5 | 358 | 3 | 162 |
| 2022 | 2 | — | 0 | 276 |
| 2023 | 2 | — | 0 | 470 |
| 2024 | 3 | 29 | 4 | 401 |
| 2025 | 4 | 89 | 0 | 1,020 |
| 2026 | 8 | 81 | 20 | — |
What is it indicated for?
The Jostra Pediatric Arterial Cannulae are designed to be used as perfusion cannulae to return arterial blood from the extracoproeal circuit to the patient during cardiopulmonary bypass up to 6 hours or less.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012617 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012617: Jostra Arterial Perfusion Cannulae, Model a....” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012617
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026