510(k) · Cleared
ClearedSynxess Neurovascular Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Enlight Medical Technologies (Shenzhen) Co., Ltd. · MOF Guide, Wire, Catheter, Neurovasculature
Cleared on Nov 18, 2024 as substantially equivalent to K110584 (Asahi Intecc Co., Ltd., 2011) and 1 other predicate after a 234-day review. Its family tree reaches back 6 generations to 1989.
- Decided
- Nov 18, 2024
- Review
- 234 days
- Class
- Class II
- Product code
- MOF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K890505 (1989). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 5 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
- 4 generations backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
- 3 generations backK022762 Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000…Jomed, Inc. · 2002
- 2 generations backK110584 Asahi Chikai Neurovascular Guide WireAsahi Intecc Co., Ltd. · 2011
- 1 generation backK112979 Asahi Chikai 10 Neurovascular Guide WireAsahi Intecc Co., Ltd. · 2011
- This deviceK240871 Synxess Neurovascular GuidewireEnlight Medical Technologies (Shenzhen) Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K890505 | Usci Grey/Black Guide Wire | C.R. Bard, Inc. | 1989 | — |
| −5 | K961271 | Usci Commander Series Guide Wires | C.R. Bard, Inc. | 1996 | — |
| −4 | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat… | Guidant Corp. | 1999 | — |
| −3 | K022762 | Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000… | Jomed, Inc. | 2002 | — |
| −2 | K110584 | Asahi Chikai Neurovascular Guide Wire | Asahi Intecc Co., Ltd. | 2011 | — |
| −1 | K112979 | Asahi Chikai 10 Neurovascular Guide Wire | Asahi Intecc Co., Ltd. | 2011 | — |
| 0 (this device) | K240871 | Synxess Neurovascular Guidewire | Enlight Medical Technologies (Shenzhen) Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 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 MOF? 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 MOF device
- #1 K253168 0.014” Willow Guidewirescore 17.9 · 6 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 |
|---|---|---|---|
| * | K110584 | Asahi Chikai Neurovascular Guide WireSummary page 5…Number: 21 CFR 870.1330 Product Code: MOF Classification: Class II Predicate Devices: Predicate: ASAHI CHIKAI Neurovascular Guide Wire (K110584, product code MOF) Predicate: ASAHI CHIKAI 10 Neurovascular Guide Wire (K112979, product code MOF) Indications for Use Statemen… | 2011 |
| * | K112979 | Asahi Chikai 10 Neurovascular Guide WireSummary page 5…Class II Predicate Devices: Predicate: ASAHI CHIKAI Neurovascular Guide Wire (K110584, product code MOF) Predicate: ASAHI CHIKAI 10 Neurovascular Guide Wire (K112979, product code MOF) Indications for Use Statement Synxess Neurovascular Guidewire is intended to be used in the neuro vasculatur… | 2011 |
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 35 years and passes through 5 companies; a new generation was cleared every 7.0 years on median.
- None of the 11 ancestors has a recall.
- 5 other devices also cite its predicate K110584.
How does its category compare?
All MOF devicesMOF Guide, Wire, Catheter, Neurovasculature: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · MOF
11so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · MOF
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MOF
No recall names MOF since 2007.
Adverse event reports per year · MOF
135in 2025
MAUDE reports naming product code MOF, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 3 | 133 | 0 | 5 |
| 2016 | 4 | 61 | 0 | 3 |
| 2017 | 1 | — | 0 | 15 |
| 2018 | 2 | — | 0 | 11 |
| 2019 | 4 | 58 | 0 | 12 |
| 2020 | 4 | 36 | 0 | 18 |
| 2021 | 0 | — | 0 | 39 |
| 2022 | 1 | — | 0 | 92 |
| 2023 | 4 | 199 | 0 | 91 |
| 2024 | 2 | — | 0 | 95 |
| 2025 | 5 | 172 | 0 | 135 |
| 2026 | 11 | 192 | 0 | — |
What is it indicated for?
Synxess Neurovascular Guidewire is intended to be used in the neuro vasculature to facilitate the placement and exchange of therapeutic devices such as cerebral catheters during intravascular therapy. This guidewire is intended for use only in the neuro vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240871 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240871: Synxess Neurovascular Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240871
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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