510(k) · Cleared
ClearedRX Accunet Embolic Protection System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guidant Corporation · NTE Temporary Carotid Catheter For Embolic Capture
Cleared on Aug 16, 2005 as substantially equivalent to K042218 (Guidant Corp., 2004) after a 7-day review. Its family tree reaches back 3 generations to 2001. 1 later device descends from it.
- Decided
- Aug 16, 2005
- Review
- 7 days
- Class
- Class II
- Product code
- NTE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K003992 (2001). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK003992 Percusurge Guardwire Temporary Occlusion and Aspiration SystemPercu Surge, Inc. · 2001
- 2 generations backK023691 Boston Scientific Filterwire EX EmbolicBoston Scientific Epi · 2003
- 1 generation backK042218 Accunet Embolic Protection System, RX Accunet Embolic Protection…Guidant Corp. · 2004
- This deviceK052165 RX Accunet Embolic Protection SystemGuidant Corporation · 2005
- Descendant · cites it directly · 0 of its ownK081549 RX Accunet LP Embolic Protection SystemAbbott Laboratories · 2008 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K081549RX Accunet LP Embolic Protection SystemAbbott Laboratories · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003992 | Percusurge Guardwire Temporary Occlusion and Aspiration System | Percu Surge, Inc. | 2001 | — |
| −2 | K023691 | Boston Scientific Filterwire EX Embolic | Boston Scientific Epi | 2003 | — |
| −1 | K042218 | Accunet Embolic Protection System, RX Accunet Embolic Protection System | Guidant Corp. | 2004 | — |
| 0 (this device) | K052165 | RX Accunet Embolic Protection System | Guidant Corporation | 2005 | — |
| +1 | K081549 | RX Accunet LP Embolic Protection System | Abbott Laboratories | 2008 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K042218 | Accunet Embolic Protection System, RX Accunet Embolic Protection SystemSummary page 4…11 Summary of Substantial Equivalence: The RX ACCUINET TM Embolic Protection System is substantially equivalent to the RX ACCUINET TM Embolic Protection System (K(042218). Device Description: The RX ACCUINET TM Embolic Protection System is a filtration type embolic protection TM device,… | 2004 |
| Kept off the family tree | K024418 | RX ACCUNET Embolic Protection System Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 5…Guide Wire, Delivery Sheath, or Recovery Catheter. The RX ACCUNET M Embolic Protection System is substantially equivalent to the RX ACCUNET Embolic Protection System (K024418) with regard to device design, principles of operation, materials, and indications for use. The following design attributes are… |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081549 | RX Accunet LP Embolic Protection System | 2008 | 0 |
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 4 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K081549 (Abbott Laboratories, 2008) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K042218.
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.
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™ Embolic Protection System is indicated for use as a guide wire 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 3.25 mm and 7.0 mm.
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/K052165 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052165: RX Accunet 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/K052165
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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