510(k) · Cleared
ClearedpORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phenox Limited · DQX Wire, Guide, Catheter
Cleared on Oct 9, 2019 as substantially equivalent to K093397 (MicroVention, Inc., 2009) and 1 other predicate after a 107-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Oct 9, 2019
- Review
- 107 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K953533 (1995). 9 ancestors in all, the oldest K934122 (1993). No later device cites it as a predicate yet.
- Root · 5 generations backK953533 Radifocus Glidewire for Coronary Use with Platinum (or Gold) CoilTerumo Medical Corp. · 1995
- 4 generations backK961445 Radifocus Glidewire for Coronary Use with Platinum (or Gold) CoilTerumo Medical Corp. · 1996
- 3 generations backK063695 Runthrough NSTerumo Medical Corp. · 2007 · Recalled
- 2 generations backK080563 Runthrough NS Extension WireTerumo Medical Corp. · 2008
- 1 generation backK093397 Traxcess 14EX Guidewire and Traxcess Docking WireMicroVention, Inc. · 2009
- This deviceK191687 pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension WirePhenox Limited · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K953533 | Radifocus Glidewire for Coronary Use with Platinum (or Gold) Coil | Terumo Medical Corp. | 1995 | — |
| −4 | K961445 | Radifocus Glidewire for Coronary Use with Platinum (or Gold) Coil | Terumo Medical Corp. | 1996 | — |
| −3 | K063695 | Runthrough NS | Terumo Medical Corp. | 2007 | 1 |
| −2 | K080563 | Runthrough NS Extension Wire | Terumo Medical Corp. | 2008 | — |
| −1 | K093397 | Traxcess 14EX Guidewire and Traxcess Docking Wire | MicroVention, Inc. | 2009 | — |
| 0 (this device) | K191687 | pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire | Phenox Limited | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2008 | 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 DQX? 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 DQX device
- #1 K213854 SavvyWirescore 15.7 · 10 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 |
|---|---|---|---|
| * | K093397 | Traxcess 14EX Guidewire and Traxcess Docking WireSummary page 4…Guidewire Classification: Class II, 21 CFR 870.1330, Catheter Guide wire Product Code: MOF III. PREDICATE DEVICE(S) Traxcess 14EX Guidewire and Traxcess Docking Wire, K093397, Cleared Dec 2009. Transend EX Guidewire, K934122, cleared October 1993. IV. DEVICE DESCRIPTION The pORTAL Steerable Hydrophili… | 2009 |
| * | K934122 | Scimed Transend EX Steerable Guide Wire and AccessoriesSummary page 4…30, Catheter Guide wire Product Code: MOF III. PREDICATE DEVICE(S) Traxcess 14EX Guidewire and Traxcess Docking Wire, K093397, Cleared Dec 2009. Transend EX Guidewire, K934122, cleared October 1993. IV. DEVICE DESCRIPTION The pORTAL Steerable Hydrophilic Guidewire is a disposable medical device designe… | 1993 |
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 24 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- 1 of the 9 ancestors has a recall of any class.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · DQX
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQX
177in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQX
3in 2024
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · DQX
2,178in 2025
MAUDE reports naming product code DQX, 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 | 14 | 85 | 12 | 760 |
| 2008 | 19 | 87 | 7 | 715 |
| 2009 | 18 | 87 | 49 | 687 |
| 2010 | 21 | 63 | 34 | 987 |
| 2011 | 18 | 43 | 3 | 1,311 |
| 2012 | 20 | 62 | 5 | 1,337 |
| 2013 | 18 | 119 | 7 (4) | 1,474 |
| 2014 | 18 | 103 | 0 | 1,323 |
| 2015 | 15 | 112 | 1 | 1,323 |
| 2016 | 14 | 179 | 2 (2) | 1,466 |
| 2017 | 19 | 85 | 17 | 1,524 |
| 2018 | 19 | 114 | 9 | 1,737 |
| 2019 | 13 | 173 | 2 | 1,679 |
| 2020 | 14 | 106 | 1 (1) | 1,536 |
| 2021 | 6 | 161 | 0 | 1,713 |
| 2022 | 15 | 212 | 0 | 1,647 |
| 2023 | 10 | 136 | 0 | 2,068 |
| 2024 | 11 | 134 | 3 | 2,210 |
| 2025 | 10 | 177 | 0 | 2,178 |
| 2026 | 12 | 145 | 4 (1) | — |
What is it indicated for?
The pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire is intended for use in the neuro vasculature. The wire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in peripheral or coronary arteries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191687 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191687: pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191687
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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