510(k) · Cleared
ClearedBunegin-Albin Air Aspiration Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · DXE Catheter, Embolectomy
Cleared on Jul 27, 2017 as substantially equivalent to K130536 (Medtronic, Inc., 2013) after a 269-day review. Its family tree reaches back 7 generations to 2001.
- Decided
- Jul 27, 2017
- Review
- 269 days
- Class
- Class II
- Product code
- DXE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K010579 (2001). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK010579 Stent Support Guide CatheterMedtronic Vascular · 2001 · Recalled
- 6 generations backK030201 Modification to Export Aspiration CatheterMedtronic Vascular · 2003
- 5 generations backK040869 Export CatheterMedtronic Vascular · 2004
- 4 generations backK061958 Medtronic Export XT CatheterMedtronic Vascular · 2006 · Recalled
- 3 generations backK081573 Medtronic Export AP CatheterMedtronic Vascular · 2008
- 2 generations backK120808 Export XT Catheter, Export AP CatheterMedtronic, Inc. · 2012
- 1 generation backK130536 Export Advance Aspiration CatheterMedtronic, Inc. · 2013
- This deviceK163031 Bunegin-Albin Air Aspiration SetCook Incorporated · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K010579 | Stent Support Guide Catheter | Medtronic Vascular | 2001 | 27 |
| −6 | K030201 | Modification to Export Aspiration Catheter | Medtronic Vascular | 2003 | — |
| −5 | K040869 | Export Catheter | Medtronic Vascular | 2004 | — |
| −4 | K061958 | Medtronic Export XT Catheter | Medtronic Vascular | 2006 | 1 |
| −3 | K081573 | Medtronic Export AP Catheter | Medtronic Vascular | 2008 | — |
| −2 | K120808 | Export XT Catheter, Export AP Catheter | Medtronic, Inc. | 2012 | — |
| −1 | K130536 | Export Advance Aspiration Catheter | Medtronic, Inc. | 2013 | — |
| 0 (this device) | K163031 | Bunegin-Albin Air Aspiration Set | Cook Incorporated | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2003 | 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 DXE? 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 DXE device
- #1 K240078 Fogarty Thru-Lumen Embolectomy Catheterscore 7.9 · 1 generation · 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 |
|---|---|---|---|
| * | K130536 | Export Advance Aspiration CatheterSummary page 4…Cardiovascular Predicate Device: The Bunegin-Albin Air Aspiration Set is substantially equivalent to the following device: the Export Advance™ Aspiration Catheter (K130536, Medtronic Inc.) cleared on July 16, 2013. Device Description: The Bunegin-Albin Air Aspiration Set is comprised of an air aspi… | 2013 |
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 16 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- 3 of the 11 ancestors have a recall of any class.
- 2 other devices also cite its predicate K130536.
How does its category compare?
All DXE devicesDXE Catheter, Embolectomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · DXE
5in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DXE
173in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXE
1in 2023
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · DXE
306in 2025
MAUDE reports naming product code DXE, 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 | 0 | — | 3 | 167 |
| 2008 | 1 | — | 0 | 134 |
| 2009 | 0 | — | 5 | 124 |
| 2010 | 2 | — | 1 | 136 |
| 2011 | 0 | — | 1 | 164 |
| 2012 | 0 | — | 0 | 200 |
| 2013 | 0 | — | 0 | 150 |
| 2014 | 0 | — | 0 | 192 |
| 2015 | 1 | — | 13 | 266 |
| 2016 | 0 | — | 0 | 796 |
| 2017 | 2 | — | 0 | 770 |
| 2018 | 0 | — | 0 | 615 |
| 2019 | 0 | — | 0 | 594 |
| 2020 | 1 | — | 0 | 547 |
| 2021 | 1 | — | 4 (4) | 333 |
| 2022 | 1 | — | 3 | 463 |
| 2023 | 0 | — | 1 | 436 |
| 2024 | 5 | 173 | 0 | 377 |
| 2025 | 0 | — | 0 | 306 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
The Bunegin-Albin Air Aspiration Set is intended to aspirate venous air emboli.
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/K163031 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163031: Bunegin-Albin Air Aspiration Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163031
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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