510(k) · Cleared
ClearedHydrophilic 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 Dec 19, 2003 as substantially equivalent to K770977 (Lake Region Mfg., Inc., 1977) and 1 other predicate after a 17-day review. Its family tree reaches back 1 generation to 1977. 4 later devices descend from it.
- Decided
- Dec 19, 2003
- Review
- 17 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K770977 (1977). 2 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK770977 Cardiovascular Spring GuidesLake Region Mfg., Inc. · 1977 · Recalled
- This deviceK033758 Hydrophilic GuidewireLake Region Mfg., Inc. · 2003
- Descendant · cites it directly · 2 of its ownK140485 Mandrel GuidewireLake Region Medical · 2014
- Descendant · 2 generations on · 1 of its ownK142393 Predicate Iii GuidewireLake Region Medical · 2014
- Descendant · 3 generations on · 0 of its ownK241784 Arrow® Nitinol WireTeleflex Medical · 2024
- Descendant · cites it directly · 0 of its ownK081775 The Medcomp .010 Vascular GuidewiresMedcomp · 2009
Most influential descendants
Showing 4 of 4 · See all- K140485Mandrel GuidewireLake Region Medical · 2014 · cites it directly2descendants
- K142393Predicate Iii GuidewireLake Region Medical · 2014 · 2 generations on1descendant
- K241784Arrow® Nitinol WireTeleflex Medical · 2024 · 3 generations on0descendants
- 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 | K770977 | Cardiovascular Spring Guides | Lake Region Mfg., Inc. | 1977 | 1 |
| 0 (this device) | K033758 | Hydrophilic Guidewire | Lake Region Mfg., Inc. | 2003 | — |
| +1 | K140485 | Mandrel Guidewire | Lake Region Medical | 2014 | — |
| +2 | K142393 | Predicate Iii Guidewire | Lake Region Medical | 2014 | — |
| +3 | K241784 | Arrow® Nitinol Wire | Teleflex Medical | 2024 | — |
| +1 | K081775 | The Medcomp .010 Vascular Guidewires | Medcomp | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2014 | 2 | 0 |
| 2024 | 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? (2)
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 |
|---|---|---|---|
| * | K770977 | Cardiovascular Spring GuidesSummary page 2…4.2 Engineering Specifications The design specifications are the same for the proposed device as they are for the LRM predicate devices [reference 5 10(k) K770977 and KOl1 1084]. The finished device with hydrophilic coating must meet the same basic design criteria and also meet t… | 1977 |
| * | K011084 | Mandrel Guidewire AssemblySummary page 2…e core is enclosed in the coil as in K779077 design) or at a design-driven location on the core (where a portion of the core is exposed as in K01 1084 design). A portion of the guidewire is coated with hydrophilic coating. The guidewires are bound by the… | 2001 |
| † | K991898 | Ultra-Select Guidewire, Hytek Guidewire | 1999 |
What descends from it? (4)
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)
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?
To facilitate the placement of devices for diagnostic and interventional procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033758 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033758: Hydrophilic Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033758
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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