510(k) · Cleared
ClearedCentrimag Drainage Cannula Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Levitronix, LLC · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cleared on Jun 20, 2011 as substantially equivalent to K870109 (Research Medical, Inc., 1987) after a 74-day review. Its family tree reaches back 1 generation to 1987. 3 later devices descend from it.
- Decided
- Jun 20, 2011
- Review
- 74 days
- Class
- Class II
- Product code
- DWF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K870109 (1987). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK870109 Rmi Venous Drainage CannulaResearch Medical, Inc. · 1987
- This deviceK110983 Centrimag Drainage Cannula KitLevitronix, LLC · 2011
- Descendant · cites it directly · 2 of its ownK152190 Thoratec CentriMag Drainage (Venous) Cannula KitThoratec Corporation · 2015
- Descendant · 2 generations on · 1 of its ownK200306 CentriMag Circulatory Support System, CentriMag Return (Arterial)…Abbott (Formerly Thoratec Corporation) · 2020
- Descendant · 3 generations on · 0 of its ownK234118 CentriMag™ Acute Circulatory Support SystemAbbott Medical · 2024
Most influential descendants
Showing 3 of 3 · See all- K152190Thoratec CentriMag Drainage (Venous) Cannula KitThoratec Corporation · 2015 · cites it directly2descendants
- K200306CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag…Abbott (Formerly Thoratec Corporation) · 2020 · 2 generations on1descendant
- K234118CentriMag™ Acute Circulatory Support SystemAbbott Medical · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K870109 | Rmi Venous Drainage Cannula | Research Medical, Inc. | 1987 | — |
| 0 (this device) | K110983 | Centrimag Drainage Cannula Kit | Levitronix, LLC | 2011 | — |
| +1 | K152190 | Thoratec CentriMag Drainage (Venous) Cannula Kit | Thoratec Corporation | 2015 | — |
| +2 | K200306 | CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit… | Abbott (Formerly Thoratec Corporation) | 2020 | — |
| +3 | K234118 | CentriMag™ Acute Circulatory Support System | Abbott Medical | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K870109 | Rmi Venous Drainage CannulaSummary page 1…Device Predicate Predicate 510(k) CentriMag Drainage Cannula Kit Edwards Lifesciences K8701091 Venous Dramna e Cannula 510k originally issued to Research Medical, Inc… | 1987 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152190 | Thoratec CentriMag Drainage (Venous) Cannula Kit | 2015 | 2 |
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.
- Of its descendants, K152190 (Thoratec Corporation, 2015) has gone furthest, with 2 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. 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 CentriMag Drainage Cannula is intended to be used as a venous drainage cannula with an extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110983 · printed Nov 5, 2026
Cite this page
510(k) Report. “K110983: Centrimag Drainage Cannula Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110983
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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