510(k) · Cleared
ClearedModification to: RX 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 18, 2005 as substantially equivalent to K042218 (Guidant Corp., 2004) and 1 other predicate after a 9-day review. Its family tree reaches back 3 generations to 2001. 2 of the 19 devices in its family, counting itself, have a Class I recall. 13 later devices descend from it.
- Decided
- Aug 18, 2005
- Review
- 9 days
- Class
- Class II
- Product code
- NTE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K003992 (2001). 5 ancestors in all. 13 later devices descend from it, 3 citing it directly. 2 of the 19 devices in this family, counting this one, have a Class I recall.
- 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 deviceK052166 Modification to: RX Accunet Embolic Protection SystemGuidant Corporation · 2005
- Descendant · cites it directly · 8 of its ownK072990 Guardwire Temporary Occlusion and Aspiration System- CarotidMedtronic, Inc. · 2007
- Descendant · 2 generations on · 5 of its ownK083300 Gore Flow Reversal SystemW. L. Gore & Associates, Inc. · 2009
- Descendant · cites it directly · 2 of its ownK153086 RX ACCUNET Embolic Protection SystemAbbott Vascular · 2015
- Descendant · 3 generations on · 2 of its ownK143072 ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc. · 2015
- Descendant · 2 generations on · 1 of its ownK181128 Paladin Carotid Post-dilation Balloon System with Integrated Embolic…Contego Medical, LLC · 2018
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 13 · See all- K072990Guardwire Temporary Occlusion and Aspiration System- CarotidMedtronic, Inc. · 2007 · cites it directly8descendants
- K083300Gore Flow Reversal SystemW. L. Gore & Associates, Inc. · 2009 · 2 generations on5descendants
- K153086RX ACCUNET Embolic Protection SystemAbbott Vascular · 2015 · cites it directly2descendants
- K143072ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc. · 2015 · 3 generations on2descendants
- K181128Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin…Contego Medical, LLC · 2018 · 2 generations on1descendant
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) | K052166 | Modification to: RX Accunet Embolic Protection System | Guidant Corporation | 2005 | — |
| +1 | K072990 | Guardwire Temporary Occlusion and Aspiration System- Carotid | Medtronic, Inc. | 2007 | — |
| +2 | K083300 | Gore Flow Reversal System | W. L. Gore & Associates, Inc. | 2009 | — |
| +1 | K153086 | RX ACCUNET Embolic Protection System | Abbott Vascular | 2015 | — |
| +3 | K143072 | ENROUTE Transcarotid Neuroprotection System | Silk Road Medical, Inc. | 2015 | — |
| +2 | K181128 | Paladin Carotid Post-dilation Balloon System with Integrated Embolic… | Contego Medical, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 1 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 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 |
|---|---|---|---|
| * | K042218 | Accunet Embolic Protection System, RX Accunet Embolic Protection SystemSummary page 5…TM Embolic Protection System. The RX ACCUNET T MEmbolic Protection System is substantially equivalent toTM the RX ACCUNETTM Embolic Protection Systems (K042218) and the RX ACCUNET 2 Recovery Catheter (K042908) with regard to device design, principles of operation, materials, and indicatio… | 2004 |
| * | K042908 | RX Accunet 2 Embolic Protection SystemSummary page 5…he RX ACCUNET T MEmbolic Protection System is substantially equivalent toTM the RX ACCUNETTM Embolic Protection Systems (K042218) and the RX ACCUNET 2 Recovery Catheter (K042908) with regard to device design, principles of operation, materials, and indications for use. The following design attributes are t… | 2004 |
What descends from it? (13)
See all 133 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- K153485ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc. · 2016 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K230402ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical · 2023 · 5 generations on · ◆ in the 2023 descendants bar of FIG. 11 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 5 ancestors has a recall.
- Of its descendants, K072990 (Medtronic, Inc., 2007) has gone furthest, with 8 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/K052166 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052166: Modification to: 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/K052166
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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