510(k) · Cleared
ClearedModification to Ultra-Select Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microvena Corp. · DQX Wire, Guide, Catheter
Cleared on May 5, 1999 as substantially equivalent to K922060 (Microvena Corp., 1993) after a 27-day review. Its family tree reaches back 1 generation to 1993. 2 later devices descend from it.
- Decided
- May 5, 1999
- Review
- 27 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K922060 (1993). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK922060 .25' Ultra-Select GuidewireMicrovena Corp. · 1993
- This deviceK991194 Modification to Ultra-Select GuidewireMicrovena Corp. · 1999
- Descendant · cites it directly · 1 of its ownK991898 Ultra-Select Guidewire, Hytek GuidewireMicrovena Corp. · 1999
- Descendant · 2 generations on · 0 of its ownK031442 PBN GuidewiresMedical Device Technologies, Inc. · 2003
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922060 | .25' Ultra-Select Guidewire | Microvena Corp. | 1993 | — |
| 0 (this device) | K991194 | Modification to Ultra-Select Guidewire | Microvena Corp. | 1999 | — |
| +1 | K991898 | Ultra-Select Guidewire, Hytek Guidewire | Microvena Corp. | 1999 | — |
| +2 | K031442 | PBN Guidewires | Medical Device Technologies, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K922060 | .25' Ultra-Select GuidewireSummary page 1…: HyTek™ Guidewire Classification Name: Wire, Guide, Catheter Classification Code: 74 DQX 3. Substantial Equivalency: The HyTek guidewire is substantially equivalent to K922060. 4. Device Description and Intended Use: The MICROVENA HyTek Guidewire is designed to fit inside a catheter, for directing the… | 1993 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991898 | Ultra-Select Guidewire, Hytek Guidewire | 1999 | 1 |
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?
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 0.025” HyTek guidewire is indicated for use in the peripheral vasculature. The 0.014”. 0.016”, and 0.018” HyTek Guidewires are indicated for use in the peripheral and coronary vascularure.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991194 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991194: Modification to Ultra-Select Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991194
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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