510(k) · Cleared
Recalled · Class I · 2026ENROUTE® Transcarotid Neuroprotection System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Silk Road Medical · NTE Temporary Carotid Catheter For Embolic Capture
Cleared on Apr 11, 2023 as substantially equivalent to K153485 (Silk Road Medical, Inc., 2016) after a 55-day review. Its family tree reaches back 8 generations to 2001. 2 of the 31 devices in its family, counting itself, have a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- Apr 11, 2023
- Review
- 55 days
- Class
- Class II
- Product code
- NTE
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 8 generations to K003992 (2001). 30 ancestors in all, the oldest K990487 (1999). No later device cites it as a predicate yet. 2 of the 31 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK003992 Percusurge Guardwire Temporary Occlusion and Aspiration SystemPercu Surge, Inc. · 2001
- 7 generations backK023691 Boston Scientific Filterwire EX EmbolicBoston Scientific Epi · 2003
- 6 generations backK042218 Accunet Embolic Protection System, RX Accunet Embolic Protection…Guidant Corp. · 2004
- 5 generations backK052166 Modification to: RX Accunet Embolic Protection SystemGuidant Corporation · 2005
- 4 generations backK072990 Guardwire Temporary Occlusion and Aspiration System- CarotidMedtronic, Inc. · 2007
- 3 generations backK083300 Gore Flow Reversal SystemW. L. Gore & Associates, Inc. · 2009
- 2 generations backK143072 ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc. · 2015
- 1 generation backK153485 ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc. · 2016 · Recalled (Class I)
- This deviceK230402 ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical · 2023
Class I recalls in this family
- K153485 ENROUTE Transcarotid Neuroprotection Systemdirect predicate · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K003992 | Percusurge Guardwire Temporary Occlusion and Aspiration System | Percu Surge, Inc. | 2001 | — |
| −7 | K023691 | Boston Scientific Filterwire EX Embolic | Boston Scientific Epi | 2003 | — |
| −6 | K042218 | Accunet Embolic Protection System, RX Accunet Embolic Protection System | Guidant Corp. | 2004 | — |
| −5 | K052166 | Modification to: RX Accunet Embolic Protection System | Guidant Corporation | 2005 | — |
| −4 | K072990 | Guardwire Temporary Occlusion and Aspiration System- Carotid | Medtronic, Inc. | 2007 | — |
| −3 | K083300 | Gore Flow Reversal System | W. L. Gore & Associates, Inc. | 2009 | — |
| −2 | K143072 | ENROUTE Transcarotid Neuroprotection System | Silk Road Medical, Inc. | 2015 | — |
| −1 | K153485 | ENROUTE Transcarotid Neuroprotection System | Silk Road Medical, Inc. | 2016 | Class I |
| 0 (this device) | K230402 | ENROUTE® Transcarotid Neuroprotection System | Silk Road Medical | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2001 | 5 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 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.
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? (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 |
|---|---|---|---|
| * | K153485 | ENROUTE Transcarotid Neuroprotection SystemSummary page 4…pture Commun Name: Percutaneous Catheter Classification Regulation: 870.1250 Product Code: NTE 1.5. Predicate Device 510K Number & Date: K153485 on March 10, 2016 Device Name: Enroute Transcarotid Neuroprotection System Predicate Device 510(k) Number/ Clearance… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 9, 2026 | Class I | Z-2978-2026 | Under Investigation by firm | Potential for arterial sheath tip separation or partial tip separation during use. |
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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 22 years and passes through 8 companies; a new generation was cleared every 2.0 years on median.
- 5 of the 30 ancestors have a recall of any class; 1 has a Class I recall.
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. 2023, 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 ENROUTE Transcarotid Neuroprotection System is intended to provide transcarotid vascular access, introduction of diagnostic agents and therapeutic devices, and embolic protection during carotid artery angioplasty and stenting procedures for patients diagnosed with carotid artery stenosis and who have appropriate anatomy described below:
• Adequate femoral venous access
• Common carotid artery reference diameter of at least 6mm
• Carotid bifurcation is a minimum of 5 cm above the clavicle as measured by duplex Doppler ultrasound (DUS) or computerized axial tomopgraphy (CT) angiography or magnetic resonance (MR) angiography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230402 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230402: ENROUTE® Transcarotid Neuroprotection System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230402
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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