510(k) · Cleared
Recalled · 2008Medtronic Bio-Medicus Femoral Cannula/Introducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Bio-Medicus, Inc. · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cleared on Mar 26, 1993 after a 193-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 64 devices in its family, counting itself, have a Class I recall. 63 later devices descend from it. It has been recalled once.
- Decided
- Mar 26, 1993
- Review
- 193 days
- Class
- Class II
- Product code
- DWF
- Recalls
- 1
- Predicates
- 0
63 later devices descend from it, 10 citing it directly. 2 of the 64 devices in this family, counting this one, have a Class I recall.
- This deviceK924642 Medtronic Bio-Medicus Femoral Cannula/IntroducerMedtronic Bio-Medicus, Inc. · 1993
- Descendant · cites it directly · 27 of its ownK012512 Setpoint Endovascular Temperature Management SystemRadiant Medical · 2002
- Descendant · 2 generations on · 16 of its ownK022366 Celsius Control SystemInnercool Therapies · 2003
- Descendant · 2 generations on · 15 of its ownK030421 Alsius Coolgard 3000 & Alsius Catheter SystemAlsius Corp. · 2003 · Recalled
- Descendant · cites it directly · 15 of its ownK031827 Ultraflex Venous Cannula, Model 970XX and CB970XXMedtronic Perfusion Systems · 2003
- Descendant · cites it directly · 9 of its ownK052570 Tandemheart Transseptal Cannula Set-EF, Model 5140-6221Cardiacassist, Inc. · 2006 · Recalled
Showing 5 of 63 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 63 · See all- K012512Setpoint Endovascular Temperature Management SystemRadiant Medical · 2002 · cites it directly27descendants
- K022366Celsius Control SystemInnercool Therapies · 2003 · 2 generations on16descendants
- K030421Alsius Coolgard 3000 & Alsius Catheter SystemAlsius Corp. · 2003 · 2 generations on15descendants
- K031827Ultraflex Venous Cannula, Model 970XX and CB970XXMedtronic Perfusion Systems · 2003 · cites it directly15descendants
- K052570Tandemheart Transseptal Cannula Set-EF, Model 5140-6221Cardiacassist, Inc. · 2006 · cites it directly9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K924642 | Medtronic Bio-Medicus Femoral Cannula/Introducer | Medtronic Bio-Medicus, Inc. | 1993 | — |
| +1 | K012512 | Setpoint Endovascular Temperature Management System | Radiant Medical | 2002 | — |
| +2 | K022366 | Celsius Control System | Innercool Therapies | 2003 | — |
| +2 | K030421 | Alsius Coolgard 3000 & Alsius Catheter System | Alsius Corp. | 2003 | 4 |
| +1 | K031827 | Ultraflex Venous Cannula, Model 970XX and CB970XX | Medtronic Perfusion Systems | 2003 | — |
| +1 | K052570 | Tandemheart Transseptal Cannula Set-EF, Model 5140-6221 | Cardiacassist, Inc. | 2006 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 5 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 5 | 1 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 7 | 1 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have a Class I recall. 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (63)
See all 6310 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012512 | Setpoint Endovascular Temperature Management System | 2002 | 27 |
| K031827 | Ultraflex Venous Cannula, Model 970XX and CB970XX | 2003 | 15 |
| K052570 | Tandemheart Transseptal Cannula Set-EF, Model 5140-6221 | 2006 | 9 |
| K133236 | Tandemheart Femoral Venous Cannula Set | 2014 | 8 |
| K063723 | Impella Recover LP 2.5 Percutaneous Cardiac Support System | 2008 | 7 |
| K111972 | Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity… | 2011 | 5 |
| K120543 | Tandemheart Femoral Arterial Cannula Set | 2012 | 1 |
| K102532 | HLS Cannula Non-Coated, with Bioline Coating and with Softline Coating | 2011 | 1 |
| K133293 | 15 FR. Tandemheart Arterial Cannula | 2014 | 0 |
| K131666 | Arterial HLS Cannula 13 FR Non-Coated, with Bioline Coating and with Softline Coating | 2013 | 0 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 9, 2008 | Not classified | Z-1928-2008 | Nonconforming Material/Component | Medtronic is recalling selected Carmeda-coated cardiopulmonary bypass (CPB) products (e.g., oxygenators, reservoirs, pumps, cannulae and tubing packs) that were manufactured with contaminated heparin. Medtronic's heparin supplier recently… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- Of its descendants, K012512 (Radiant Medical, 2002) has gone furthest, with 27 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 | — |
https://510kreport.com/device/K924642 · printed Nov 6, 2026
Cite this page
510(k) Report. “K924642: Medtronic Bio-Medicus Femoral Cannula/Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K924642
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026