510(k) · Cleared
ClearedTalWire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Embrace Medical, Ltd. · DQX Wire, Guide, Catheter
Cleared on Jul 14, 2023 as substantially equivalent to K112631 (Vascular Solutions, Inc., 2011) after a 207-day review. Its family tree reaches back 6 generations to 2001.
- Decided
- Jul 14, 2023
- Review
- 207 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K011084 (2001). 8 ancestors in all, the oldest K971322 (1998). No later device cites it as a predicate yet.
- Root · 6 generations backK011084 Mandrel Guidewire AssemblyLake Region Mfg., Inc. · 2001
- 5 generations backK013024 Selectiva GuidewireNeometrics, Inc. · 2001
- 4 generations backK031652 Vascupuncture Picc GuidewireNeometrics, Inc. · 2003
- 3 generations backK040786 Vascupuncture Picc Guidewire with Hydro-Silk CoatingNeometrics, Inc. · 2004
- 2 generations backK043398 Modification to Vascupuncture Picc GuidewireNeometrics, Inc. · 2005
- 1 generation backK112631 Vsi GuidewireVascular Solutions, Inc. · 2011
- This deviceK223791 TalWireEmbrace Medical, Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K011084 | Mandrel Guidewire Assembly | Lake Region Mfg., Inc. | 2001 | — |
| −5 | K013024 | Selectiva Guidewire | Neometrics, Inc. | 2001 | — |
| −4 | K031652 | Vascupuncture Picc Guidewire | Neometrics, Inc. | 2003 | — |
| −3 | K040786 | Vascupuncture Picc Guidewire with Hydro-Silk Coating | Neometrics, Inc. | 2004 | — |
| −2 | K043398 | Modification to Vascupuncture Picc Guidewire | Neometrics, Inc. | 2005 | — |
| −1 | K112631 | Vsi Guidewire | Vascular Solutions, Inc. | 2011 | — |
| 0 (this device) | K223791 | TalWire | Embrace Medical, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 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? (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 |
|---|---|---|---|
| * | K112631 | Vsi GuidewireSummary page 4…E Embrace Medical Ltd. believes that the Tal Wire is substantially equivalent to the following predicate device: • Vascular Solutions, Inc., VSI Guidewire, cleared under K112631. IV. DEVICE DESCRIPTION The TalWire is a family of vascular access mandrel guidewires. The TalWire is available in various sizes… | 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 22 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- None of the 8 ancestors has a recall.
- 2 other devices also cite its predicate K112631.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 TalWire is intended for percutaneous entry of peripheral vessels using the Seldinger Technique.
The TalWire is not intended for use in the coronary or cerebral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223791 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223791: TalWire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223791
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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