510(k) · Cleared
Recalled · 2011Katzen Thrombolysis Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medi-Tech, Inc. · DQX Wire, Guide, Catheter
Cleared on Apr 6, 1989 after a 205-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 6, 1989
- Review
- 205 days
- Class
- Class II
- Product code
- DQX
- Recalls
- 2
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK883880 Katzen Thrombolysis GuidewireMedi-Tech, Inc. · 1989
- Descendant · cites it directly · 1 of its ownK033569 Flowmedica Bifurcated Infusion System, Infusion Catheter and…Flowmedica, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 0 of its ownK082163 Flowmedica Benephit Infusion SystemsFlowmedica, Inc. · 2008 · Recalled
- Descendant · cites it directly · 0 of its ownK971719 Therox Infusion GuidewiresTherox, Inc. · 1997
Most influential descendants
Showing 3 of 3 · See all- K033569Flowmedica Bifurcated Infusion System, Infusion Catheter and Introducer SheathFlowmedica, Inc. · 2004 · cites it directly1descendant
- K082163Flowmedica Benephit Infusion SystemsFlowmedica, Inc. · 2008 · 2 generations on0descendants
- K971719Therox Infusion GuidewiresTherox, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K883880 | Katzen Thrombolysis Guidewire | Medi-Tech, Inc. | 1989 | — |
| +1 | K033569 | Flowmedica Bifurcated Infusion System, Infusion Catheter and Introducer Sheath | Flowmedica, Inc. | 2004 | 2 |
| +2 | K082163 | Flowmedica Benephit Infusion Systems | Flowmedica, Inc. | 2008 | 6 |
| +1 | K971719 | Therox Infusion Guidewires | Therox, Inc. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 1, 2011 | Not classified | Z-3053-2011 | Labeling mix-ups | Boston Scientific is voluntarily recalling one lot/batch of Katzen" Infusion Wires because we have identified that the label on the carton and the inner pouch indicated an incorrect device length. The labels indicate a device length of… |
| Dec 12, 2006 | Not classified | Z-0642-2007 | Other | Boston Scientific is voluntarily recalling one lot/batch of Katzen Infusion Wires because they have identified that the label on the carton may indicate a different length device than what is actually in the carton. The affected batch was… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K033569 (Flowmedica, Inc., 2004) has gone furthest, with 1 descendant of its own.
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) | — |
https://510kreport.com/device/K883880 · printed Nov 6, 2026
Cite this page
510(k) Report. “K883880: Katzen Thrombolysis Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K883880
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026