510(k) · Cleared
Recalled · Class II · 2011RX Accunet LP Embolic Protection System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · NTE Temporary Carotid Catheter For Embolic Capture
Cleared on Aug 19, 2008 as substantially equivalent to K052166 (Guidant Corporation, 2005) and 1 other predicate after a 77-day review. Its family tree reaches back 4 generations to 2001. It has been recalled once.
- Decided
- Aug 19, 2008
- Review
- 77 days
- Class
- Class II
- Product code
- NTE
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K003992 (2001). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK003992 Percusurge Guardwire Temporary Occlusion and Aspiration SystemPercu Surge, Inc. · 2001
- 3 generations backK023691 Boston Scientific Filterwire EX EmbolicBoston Scientific Epi · 2003
- 2 generations backK042218 Accunet Embolic Protection System, RX Accunet Embolic Protection…Guidant Corp. · 2004
- 1 generation backK052165 RX Accunet Embolic Protection SystemGuidant Corporation · 2005
- This deviceK081549 RX Accunet LP Embolic Protection SystemAbbott Laboratories · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K003992 | Percusurge Guardwire Temporary Occlusion and Aspiration System | Percu Surge, Inc. | 2001 | — |
| −3 | K023691 | Boston Scientific Filterwire EX Embolic | Boston Scientific Epi | 2003 | — |
| −2 | K042218 | Accunet Embolic Protection System, RX Accunet Embolic Protection System | Guidant Corp. | 2004 | — |
| −1 | K052165 | RX Accunet Embolic Protection System | Guidant Corporation | 2005 | — |
| 0 (this device) | K081549 | RX Accunet LP Embolic Protection System | Abbott Laboratories | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 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 NTE? 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 NTE device
- #1 K222694 EmPro EPS (EP4514C-190…score 6.4 · 5 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 |
|---|---|---|---|
| * | K052166 | Modification to: RX Accunet Embolic Protection SystemSummary page 1…ivalence: The proposed RX ACCUINET® LP Embolic Protection Systemnis substantially equivalent to the currently marketed RX ACCUINET® Embolic Protection System cleared in K052166 and K0521 65, respectively, on August 18, 2005. Device Description: The RX ACCUINET® LP Embolic Protection System is a low prof… | 2005 |
| * | K052165 | RX Accunet Embolic Protection SystemSummary page 1…he proposed RX ACCUINET® LP Embolic Protection Systemnis substantially equivalent to the currently marketed RX ACCUINET® Embolic Protection System cleared in K052166 and K0521 65, respectively, on August 18, 2005. Device Description: The RX ACCUINET® LP Embolic Protection System is a low profile filtratio… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 30, 2011 | Class II | Z-0757-2013 | Nonconforming Material/Component | The recall was initiated because Abbot Vascular has discovered that the identified lots of the RX Accunet Embolic Protection System may exhibit difficult removal of the peel away sheath due to higher than normal wall thickness. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- None of the 7 ancestors has a recall.
- 2 other devices also cite its predicate K052166.
How does its category compare?
All NTE devicesNTE Temporary Carotid Catheter For Embolic Capture: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · NTE
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NTE
105in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NTE
3in 2023
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · NTE
405in 2025
MAUDE reports naming product code NTE, 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 | 1 | — | 0 | 119 |
| 2008 | 3 | 95 | 6 | 368 |
| 2009 | 3 | 86 | 0 | 343 |
| 2010 | 1 | — | 0 | 294 |
| 2011 | 4 | 105 | 1 | 304 |
| 2012 | 3 | 30 | 0 | 261 |
| 2013 | 0 | — | 0 | 258 |
| 2014 | 1 | — | 0 | 199 |
| 2015 | 3 | 105 | 0 | 148 |
| 2016 | 1 | — | 0 | 148 |
| 2017 | 0 | — | 0 | 141 |
| 2018 | 1 | — | 0 | 158 |
| 2019 | 1 | — | 0 | 233 |
| 2020 | 1 | — | 0 | 238 |
| 2021 | 1 | — | 1 (1) | 327 |
| 2022 | 1 | — | 0 | 326 |
| 2023 | 2 | — | 3 | 354 |
| 2024 | 0 | — | 0 | 398 |
| 2025 | 0 | — | 0 | 405 |
| 2026 | 0 | — | 2 (2) | — |
What is it indicated for?
The RX Accunet® LP Embolic Protection System is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of filter basket placement should be between 3.25mm to 7.0mm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081549 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081549: RX Accunet LP Embolic Protection System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081549
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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