510(k) · Cleared
ClearedHydrophilic Coating Guide Wire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suzhou Hengrui Disheng Medical Co., Ltd. · DQX Wire, Guide, Catheter
Cleared on Aug 26, 2020 as substantially equivalent to K113162 (Acme-Monaco Corp., 2012) after a 240-day review. Its family tree reaches back 3 generations to 1986.
- Decided
- Aug 26, 2020
- Review
- 240 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K863138 (1986). No later device cites it as a predicate yet.
- Root · 3 generations backK863138 Terumo Radifocus Guide WireTerumo Medical Corp. · 1986
- 2 generations backK063372 Radifocus Glidewire AdvantageTerumo Medical Corp. · 2007
- 1 generation backK113162 Slidewiretm (Trademark Pending)Acme-Monaco Corp. · 2012
- This deviceK193653 Hydrophilic Coating Guide WireSuzhou Hengrui Disheng Medical Co., Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K863138 | Terumo Radifocus Guide Wire | Terumo Medical Corp. | 1986 | — |
| −2 | K063372 | Radifocus Glidewire Advantage | Terumo Medical Corp. | 2007 | — |
| −1 | K113162 | Slidewiretm (Trademark Pending) | Acme-Monaco Corp. | 2012 | — |
| 0 (this device) | K193653 | Hydrophilic Coating Guide Wire | Suzhou Hengrui Disheng Medical Co., Ltd. | 2020 | — |
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 |
|---|---|---|---|
| * | K113162 | Slidewiretm (Trademark Pending)Summary page 4…egulation Number: 21CFR Part 870.1330 Product Code: DQX Classification: Class Ⅱ Predicate device: Acme Monaco Slidewire® (K113162) Reference Device: Terumo Radifocus Guide Wire (K863138) Device Description: The Hydrophilic Coating Guide Wire con… | 2012 |
| † | K863138 | Terumo Radifocus Guide Wire | 1986 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 34 years and passes through 3 companies; a new generation was cleared every 8.1 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
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 Hydrophilic Coating Guide Wire is designed to direct a catheter to the desired anatomical location in the peripheral and coronary vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular interventions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193653 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193653: Hydrophilic Coating Guide Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193653
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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