510(k) · Cleared
ClearedJagwire (TM) Recanalization Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · DQX Wire, Guide, Catheter
Cleared on Jul 24, 1992 after a 70-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 19 later devices descend from it.
- Decided
- Jul 24, 1992
- Review
- 70 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 0
19 later devices descend from it, 5 citing it directly.
- This deviceK922302 Jagwire (TM) Recanalization GuidewireBoston Scientific Corp · 1992
- Descendant · cites it directly · 10 of its ownK021179 Disposable Guidewire, Models G-205-3545S & G-205-3545AOlympus Optical Co., Ltd. · 2002
- Descendant · 2 generations on · 8 of its ownK091417 Single Use Guidewire, Models G-240-2527S, G-240-2545S, G-240-2527A…Terumo Corp. · 2009
- Descendant · 3 generations on · 7 of its ownK122505 Single Use Preloaded Sphincterotome VOlympus Medical Systems Corp. · 2013
- Descendant · 4 generations on · 4 of its ownK141991 Single Use Preloaded Sphincterotome V (Distal Wireguided); Single…Olympus Medical Systems Copr. · 2015 · Recalled
- Descendant · cites it directly · 2 of its ownK081708 Taxi Endoscopic GuidewireLake Region Mfg., Inc. · 2008
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K021179Disposable Guidewire, Models G-205-3545S & G-205-3545AOlympus Optical Co., Ltd. · 2002 · cites it directly10descendants
- K091417Single Use Guidewire, Models G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A…Terumo Corp. · 2009 · 2 generations on8descendants
- K122505Single Use Preloaded Sphincterotome VOlympus Medical Systems Corp. · 2013 · 3 generations on7descendants
- K141991Single Use Preloaded Sphincterotome V (Distal Wireguided); Single Use SPOlympus Medical Systems Copr. · 2015 · 4 generations on4descendants
- K081708Taxi Endoscopic GuidewireLake Region Mfg., Inc. · 2008 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K922302 | Jagwire (TM) Recanalization Guidewire | Boston Scientific Corp | 1992 | — |
| +1 | K021179 | Disposable Guidewire, Models G-205-3545S & G-205-3545A | Olympus Optical Co., Ltd. | 2002 | — |
| +2 | K091417 | Single Use Guidewire, Models G-240-2527S, G-240-2545S, G-240-2527A… | Terumo Corp. | 2009 | — |
| +3 | K122505 | Single Use Preloaded Sphincterotome V | Olympus Medical Systems Corp. | 2013 | — |
| +4 | K141991 | Single Use Preloaded Sphincterotome V (Distal Wireguided); Single Use SP | Olympus Medical Systems Copr. | 2015 | 3 |
| +1 | K081708 | Taxi Endoscopic Guidewire | Lake Region Mfg., Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 3 | 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? (19)
See all 195 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K021179 (Olympus Optical Co., Ltd., 2002) has gone furthest, with 10 descendants 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/K922302 · printed Nov 6, 2026
Cite this page
510(k) Report. “K922302: Jagwire (TM) Recanalization Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K922302
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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