510(k) · Cleared
ClearedCore and Coil Assembly Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lake Region Mfg., Inc. · DQX Wire, Guide, Catheter
Cleared on Jul 22, 1998 after a 468-day review. The FDA summary names its predicate without a number. 66 later devices descend from it.
- Decided
- Jul 22, 1998
- Review
- 468 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 0
66 later devices descend from it, 2 citing it directly.
- This deviceK971322 Core and Coil Assembly GuidewireLake Region Mfg., Inc. · 1998
- Descendant · cites it directly · 51 of its ownK040010 Genesis Medical Interventional F.a.S.T. (Facilitated…Genesis Medical Interventional, Inc. · 2004
- Descendant · 2 generations on · 35 of its ownK143563 Infusion Aspiration Catheter SystemInari Medical, Inc. · 2015
- Descendant · cites it directly · 13 of its ownK012861 Vascupuncture Access WireNeometrics, Inc. · 2002
- Descendant · 2 generations on · 12 of its ownK031652 Vascupuncture Picc GuidewireNeometrics, Inc. · 2003
- Descendant · 3 generations on · 11 of its ownK040786 Vascupuncture Picc Guidewire with Hydro-Silk CoatingNeometrics, Inc. · 2004
Showing 5 of 66 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 66 · See all- K040010Genesis Medical Interventional F.a.S.T. (Facilitated Aspiration/Suction Thrombectomy)…Genesis Medical Interventional, Inc. · 2004 · cites it directly51descendants
- K143563Infusion Aspiration Catheter SystemInari Medical, Inc. · 2015 · 2 generations on35descendants
- K012861Vascupuncture Access WireNeometrics, Inc. · 2002 · cites it directly13descendants
- K031652Vascupuncture Picc GuidewireNeometrics, Inc. · 2003 · 2 generations on12descendants
- K040786Vascupuncture Picc Guidewire with Hydro-Silk CoatingNeometrics, Inc. · 2004 · 3 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971322 | Core and Coil Assembly Guidewire | Lake Region Mfg., Inc. | 1998 | — |
| +1 | K040010 | Genesis Medical Interventional F.a.S.T. (Facilitated Aspiration/Suction… | Genesis Medical Interventional, Inc. | 2004 | — |
| +2 | K143563 | Infusion Aspiration Catheter System | Inari Medical, Inc. | 2015 | — |
| +1 | K012861 | Vascupuncture Access Wire | Neometrics, Inc. | 2002 | — |
| +2 | K031652 | Vascupuncture Picc Guidewire | Neometrics, Inc. | 2003 | — |
| +3 | K040786 | Vascupuncture Picc Guidewire with Hydro-Silk Coating | Neometrics, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 9 | 0 |
| 2019 | 5 | 0 |
| 2020 | 8 | 0 |
| 2021 | 4 | 0 |
| 2022 | 4 | 0 |
| 2023 | 5 | 0 |
| 2024 | 4 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | — | Flexmedics guidewires Named without a submission number |
What descends from it? (66)
See all 662 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, K040010 (Genesis Medical Interventional, Inc., 2004) has gone furthest, with 51 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) | — |
What is it indicated for?
For percutaneous entry of peripheral vessel using the Seldinger technique,
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/K971322 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971322: Core and Coil Assembly Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971322
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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