510(k) · Cleared
ClearedLake Region Hydrophilic 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 May 17, 2004 as substantially equivalent to K003084 (Concentric Medical, Inc., 2001) after a 48-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.
- Decided
- May 17, 2004
- Review
- 48 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003084 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK003084 Concentric Hydrophilic Guidewire, Models 90011, 90012Concentric Medical, Inc. · 2001
- This deviceK040825 Lake Region Hydrophilic GuidewireLake Region Mfg., Inc. · 2004
- Descendant · cites it directly · 0 of its ownK081775 The Medcomp .010 Vascular GuidewiresMedcomp · 2009
Most influential descendants
Showing 1 of 1 · See all- K081775The Medcomp .010 Vascular GuidewiresMedcomp · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003084 | Concentric Hydrophilic Guidewire, Models 90011, 90012 | Concentric Medical, Inc. | 2001 | — |
| 0 (this device) | K040825 | Lake Region Hydrophilic Guidewire | Lake Region Mfg., Inc. | 2004 | — |
| +1 | K081775 | The Medcomp .010 Vascular Guidewires | Medcomp | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 |
|---|---|---|---|
| * | K003084 | Concentric Hydrophilic Guidewire, Models 90011, 90012Summary page 2…2.4.2 Engineering Specifications The design specifications are the same for the proposed device as they are for the predicate device (K003084). The finished devices must meet the same basic design criteria. 2.5 Substantial Equivalence Data 2.5.1… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081775 | The Medcomp .010 Vascular Guidewires | 2009 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K081775 (Medcomp, 2009) has gone furthest, with 0 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?
The Lake Region Hydrophilic Guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the coronary, peripheral, visceral and cerebral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040825 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040825: Lake Region Hydrophilic Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040825
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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