510(k) · Cleared
ClearedRX Accunet 2 Embolic Protection System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guidant Corp. · NTE Temporary Carotid Catheter For Embolic Capture
Cleared on Nov 12, 2004 after a 22-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 2 of the 21 devices in its family, counting itself, have a Class I recall. 20 later devices descend from it.
- Decided
- Nov 12, 2004
- Review
- 22 days
- Class
- Class II
- Product code
- NTE
- Recalls
- None
- Predicates
- 1
20 later devices descend from it, 2 citing it directly. 2 of the 21 devices in this family, counting this one, have a Class I recall.
- This deviceK042908 RX Accunet 2 Embolic Protection SystemGuidant Corp. · 2004
- Descendant · cites it directly · 14 of its ownK052454 The Emboshield Embolic Protection SystemAbbott Vascular Devices · 2005
- Descendant · cites it directly · 13 of its ownK052166 Modification to: RX Accunet Embolic Protection SystemGuidant Corporation · 2005
- Descendant · 2 generations on · 8 of its ownK072990 Guardwire Temporary Occlusion and Aspiration System- CarotidMedtronic, Inc. · 2007
- Descendant · 3 generations on · 5 of its ownK083300 Gore Flow Reversal SystemW. L. Gore & Associates, Inc. · 2009
- Descendant · 2 generations on · 4 of its ownK081523 Emboshield NAV6 Embolic Protection SystemAbbott Vascular-Vascular Solutions · 2008
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 20 · See all- K052454The Emboshield Embolic Protection SystemAbbott Vascular Devices · 2005 · cites it directly14descendants
- K052166Modification to: RX Accunet Embolic Protection SystemGuidant Corporation · 2005 · cites it directly13descendants
- K072990Guardwire Temporary Occlusion and Aspiration System- CarotidMedtronic, Inc. · 2007 · 2 generations on8descendants
- K083300Gore Flow Reversal SystemW. L. Gore & Associates, Inc. · 2009 · 3 generations on5descendants
- K081523Emboshield NAV6 Embolic Protection SystemAbbott Vascular-Vascular Solutions · 2008 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042908 | RX Accunet 2 Embolic Protection System | Guidant Corp. | 2004 | — |
| +1 | K052454 | The Emboshield Embolic Protection System | Abbott Vascular Devices | 2005 | — |
| +1 | K052166 | Modification to: RX Accunet Embolic Protection System | Guidant Corporation | 2005 | — |
| +2 | K072990 | Guardwire Temporary Occlusion and Aspiration System- Carotid | Medtronic, Inc. | 2007 | — |
| +3 | K083300 | Gore Flow Reversal System | W. L. Gore & Associates, Inc. | 2009 | — |
| +2 | K081523 | Emboshield NAV6 Embolic Protection System | Abbott Vascular-Vascular Solutions | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 1 |
| 2018 | 1 | 0 |
| 2019 | 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 6.5 · 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| 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 2…ere made to the RX ACCUNET Delivery System. The RX ACCUNET T M 2 Embolic Protection System is substantially equivalent to the RX ACCUNET T M Embolic Protection Systems (K024418) with regard to device design, principals of operation, materials, and indications for use. The following design attributes are t… |
What descends from it? (20)
See all 202 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 · 5 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K230402ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical · 2023 · 6 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K052454 (Abbott Vascular Devices, 2005) has gone furthest, with 14 descendants of its own.
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 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 3.25 mm and 7.0 mm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042908 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042908: RX Accunet 2 Embolic Protection System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042908
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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