510(k) · Cleared
ClearedFibernet Embolic Protection Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lumen Biomedical, Inc. · NTE Temporary Carotid Catheter For Embolic Capture
Cleared on Aug 17, 2011 as substantially equivalent to K082348 (Lumen Biomedical, Inc., 2008) after a 35-day review. Its family tree reaches back 7 generations to 2001.
- Decided
- Aug 17, 2011
- Review
- 35 days
- Class
- Class II
- Product code
- NTE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K010579 (2001). 25 ancestors in all, the oldest K003992 (2001). No later device cites it as a predicate yet.
- Root · 7 generations backK010579 Stent Support Guide CatheterMedtronic Vascular · 2001 · Recalled
- 6 generations backK030201 Modification to Export Aspiration CatheterMedtronic Vascular · 2003
- 5 generations backK040869 Export CatheterMedtronic Vascular · 2004
- 4 generations backK050139 Modification to: Export CatheterMedtronic Vascular · 2005
- 3 generations backK053372 Lbi Catheter SystemLumen Biomedical, Inc. · 2006
- 2 generations backK071529 Xtract Catheter SystemLumen Biomedical, Inc. · 2007 · Recalled
- 1 generation backK082348 Fibernet Embolic Protection SystemLumen Biomedical, Inc. · 2008 · Recalled
- This deviceK111987 Fibernet Embolic Protection DeviceLumen Biomedical, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K010579 | Stent Support Guide Catheter | Medtronic Vascular | 2001 | 27 |
| −6 | K030201 | Modification to Export Aspiration Catheter | Medtronic Vascular | 2003 | — |
| −5 | K040869 | Export Catheter | Medtronic Vascular | 2004 | — |
| −4 | K050139 | Modification to: Export Catheter | Medtronic Vascular | 2005 | — |
| −3 | K053372 | Lbi Catheter System | Lumen Biomedical, Inc. | 2006 | — |
| −2 | K071529 | Xtract Catheter System | Lumen Biomedical, Inc. | 2007 | 1 |
| −1 | K082348 | Fibernet Embolic Protection System | Lumen Biomedical, Inc. | 2008 | 2 |
| 0 (this device) | K111987 | Fibernet Embolic Protection Device | Lumen Biomedical, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 5 | 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.
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 6.5 · 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K082348 | Fibernet Embolic Protection SystemSummary page 1…tem Common Name: Embolic Protection Device Classification Name: Catheter, Percutaneous Predicate(s): FiberNet Embolic Protection System (K082348) Intended Use: The FiberNet® Embolic Protection System is indicated for use as a guidewire… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 10 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 6 of the 25 ancestors have a recall of any class.
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. 2011, 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 FiberNet® Embolic Protection System is indicated for use as a guidewire and emboli protection system to capture and remove embolic material (thrombus/debris) produced while performing percutaneous transluminal interventional procedures in carotid arteries in high surgical risk patients with reference vessel diameters of 3.5 to 7.0 mm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111987 · printed Nov 4, 2026
Cite this page
510(k) Report. “K111987: Fibernet Embolic Protection Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K111987
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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