510(k) · Cleared
ClearedCardioGard Emboli Protection Cannula
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiogard Medical, Ltd. · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cleared on May 17, 2019 as substantially equivalent to K141465 (Cardiogard Medical, Ltd., 2015) after a 266-day review. Its family tree reaches back 4 generations to 1982. 2 of the 9 devices in its family, counting itself, have a Class I recall.
- Decided
- May 17, 2019
- Review
- 266 days
- Class
- Class II
- Product code
- DWF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K820044 (1982). 8 ancestors in all. No later device cites it as a predicate yet. 2 of the 9 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK820044 Arterial Blood Filter, #AF-1025Bentley Laboratories, Inc. · 1982
- 3 generations backK022071 Embol-X Aortic Filters,Etra-Small,Small,Medium,Large,Extra…Embol-X, Inc. · 2003 · Recalled (Class I)
- 2 generations backK031946 Embol-X Intra-Aortic Filter: Extra-Small, Small, Medium, Large…Edwards Lifesciences, LLC · 2003
- 1 generation backK141465 Cardiogard Emboli Protection CannulaCardiogard Medical, Ltd. · 2015
- This deviceK182302 CardioGard Emboli Protection CannulaCardiogard Medical, Ltd. · 2019
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K820044 | Arterial Blood Filter, #AF-1025 | Bentley Laboratories, Inc. | 1982 | — |
| −3 | K022071 | Embol-X Aortic Filters,Etra-Small,Small,Medium,Large,Extra Large,Models… | Embol-X, Inc. | 2003 | Class I |
| −2 | K031946 | Embol-X Intra-Aortic Filter: Extra-Small, Small, Medium, Large, Extra-Large | Edwards Lifesciences, LLC | 2003 | — |
| −1 | K141465 | Cardiogard Emboli Protection Cannula | Cardiogard Medical, Ltd. | 2015 | — |
| 0 (this device) | K182302 | CardioGard Emboli Protection Cannula | Cardiogard Medical, Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 1 |
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.
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? (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 |
|---|---|---|---|
| * | K141465 | Cardiogard Emboli Protection CannulaSummary page 4…NCP, 21 CFR 870.4210 Review Panel: Cardiovascular Devices Class: II E. Predicate Device: K141465 CardioGard Emboli Protection Cannula F. Device Description: The CardioGard Emboli Protection Cannula (CardioGard Cannula… | 2015 |
| † | K043179 | Select 3D Arterial Cannula | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
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.
- K102420Embol-X Access Device/ Aortic Cannula, Embol-X Slim Accessdevice/ Aortic Cannula, Embol-X Glide Access…Edwards Lifesciences, LLC · 2010 · 2 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
- K022071Embol-X Aortic Filters,Etra-Small,Small,Medium,Large,Extra Large,Models CF26000.CF29000,CF32000,CF35000,CF4000Embol-X, Inc. · 2003 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 37 years and passes through 4 companies; a new generation was cleared every 11.2 years on median.
- 3 of the 8 ancestors have a recall of any class; 2 have a Class I recall.
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. 2019, 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 CardioGard Emboli Protection Cannula combines the function of a standard arterial cannula with an added suction mechanism to capture debris that may result from cardiac surgery.
The CardioGard Emboli Protection Cannula is intended for perfusion of the ascending aorta during short term (<6 hours) cardiopulmonary bypass (CPB) procedures. The CardioGard suction lumen is intended for the removal of particulate emboli during surgical procedures that require CPB.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182302 · printed Nov 4, 2026
Cite this page
510(k) Report. “K182302: CardioGard Emboli Protection Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K182302
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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