510(k) · Cleared
ClearedNovaport One Vascular Access Cannula
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novalung GmbH · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cleared on Dec 6, 2011 as substantially equivalent to K052524 (Medtronic Perfusion Systems, 2005) and 1 other predicate after a 95-day review. Its family tree reaches back 2 generations to 1984.
- Decided
- Dec 6, 2011
- Review
- 95 days
- Class
- Class II
- Product code
- DWF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K840001 (1984). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K840001 | Arterial Cannula Straight Beveled Tip | Dlp, Inc. | 1984 | 1 |
| −1 | K024069 | One Piece Pediatric Arterial Cannula, Model: 77006, 77106 | Medtronic Vascular | 2003 | 2 |
| 0 (this device) | K112565 | Novaport One Vascular Access Cannula | Novalung GmbH | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 2005 | 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? (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 |
|---|---|---|---|
| * | K052524 | Bio-Medicus Multi-Stage Venous Femoral Percutaneous KitSummary page 1…ass I1 CLASSIFICATION NAME: Cardiopulmonary bypass vascular catheter, cannula, or tubing Classification regulation: Sec. 870.4210 PRODUCT CODES: DWF PREDICATE DEVICES K052524, Bio-Medicus Multi-Stage Venous Femoral Percutaneous Kit K 024069, One Piece Pediatric Arterial Cannula 7000 Models PRODUCT DESC… | 2005 |
| * | K024069 | One Piece Pediatric Arterial Cannula, Model: 77006, 77106Summary page 1…eter, cannula, or tubing Classification regulation: Sec. 870.4210 PRODUCT CODES: DWF PREDICATE DEVICES K052524, Bio-Medicus Multi-Stage Venous Femoral Percutaneous Kit K 024069, One Piece Pediatric Arterial Cannula 7000 Models PRODUCT DESCRIPTION The NovaPort® One Vascular Access cannula with Novalung c… | 2003 |
| † | K102532 | HLS Cannula Non-Coated, with Bioline Coating and with Softline Coating | 2011 |
| † | K072362 | Novalung Surgical Lung Assist (Sla) Membrane Lung | 2007 |
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?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 18.9 years on median.
- 3 of the 4 ancestors have a recall of any class.
- 2 other devices also cite its predicate K052524.
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. 2011, this device’s year, is highlighted.
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 NovaPort® One Vascular Access cannula with its associated Introducer Kit is a percutaneous cannula intended to be used to cannulate blood vessels in patients requiring extracorporeal support such as cardiopulmonary bypass. The application of NovaPort® One cannula is limited to < 6 hours.
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/K112565 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112565: Novaport One Vascular Access Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112565
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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