510(k) · Cleared
ClearedRoll-X Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
St Jude Medical · DQX Wire, Guide, Catheter
Cleared on Apr 28, 2010 as substantially equivalent to K082304 (St Jude Medical, 2008) and 3 other predicates after a 47-day review. Its family tree reaches back 8 generations to 1989.
- Decided
- Apr 28, 2010
- Review
- 47 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K890505 (1989). 18 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 7 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
- 6 generations backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
- 5 generations backK022762 Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000…Jomed, Inc. · 2002
- 4 generations backK031277 Jowire Asahi Ptca Catheter Guide Wires, Models…Jomed, Inc. · 2003
- 3 generations backK041531 Asahi Ptca Guide Wire Confianza ProAsahi Intecc Co., Ltd. · 2004
- 2 generations backK052339 Asahi Ptca Guide WireAsahi Intecc Co., Ltd. · 2005
- 1 generation backK082304 Roll-X GuidewireSt Jude Medical · 2008
- This deviceK100710 Roll-X GuidewireSt Jude Medical · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K890505 | Usci Grey/Black Guide Wire | C.R. Bard, Inc. | 1989 | — |
| −7 | K961271 | Usci Commander Series Guide Wires | C.R. Bard, Inc. | 1996 | — |
| −6 | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat… | Guidant Corp. | 1999 | — |
| −5 | K022762 | Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000… | Jomed, Inc. | 2002 | — |
| −4 | K031277 | Jowire Asahi Ptca Catheter Guide Wires, Models… | Jomed, Inc. | 2003 | — |
| −3 | K041531 | Asahi Ptca Guide Wire Confianza Pro | Asahi Intecc Co., Ltd. | 2004 | — |
| −2 | K052339 | Asahi Ptca Guide Wire | Asahi Intecc Co., Ltd. | 2005 | — |
| −1 | K082304 | Roll-X Guidewire | St Jude Medical | 2008 | — |
| 0 (this device) | K100710 | Roll-X Guidewire | St Jude Medical | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 2000 | 1 | 0 |
| 2002 | 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? (4)
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 |
|---|---|---|---|
| * | K082304 | Roll-X GuidewireSummary page 1…ification Name: Catheter Guidewire (870.1330) Product Code: DQX 3. Predicate Device Information Roll-X'rm Guidewire (St. Jude Medical) - K082304 cleared Aug 2008 Asahi Prowater PTCA Coronary Guldewire (Abbott) - K052339 cleared Nov 2005 Hi-Torque Balance Middleweight Univer… | 2008 |
| * | K052339 | Asahi Ptca Guide WireSummary page 1…DQX 3. Predicate Device Information Roll-X'rm Guidewire (St. Jude Medical) - K082304 cleared Aug 2008 Asahi Prowater PTCA Coronary Guldewire (Abbott) - K052339 cleared Nov 2005 Hi-Torque Balance Middleweight Universal (Abbott) - K0l 3833 cleared Jan 2002 Hi-Torque Balance Heavyweight Guid… | 2005 |
| * | K013833 | HI-Toque Balance Middleweight Universal Guide Wire with Hydrocoat Hydrophilic Coating… | 2002 |
| * | K982083 | Acs HI-Torque Balance Heavyweight Guide Wire with Hydrocoat Hydrophilic CoatingSummary page 1…wire (Abbott) - K052339 cleared Nov 2005 Hi-Torque Balance Middleweight Universal (Abbott) - K0l 3833 cleared Jan 2002 Hi-Torque Balance Heavyweight Guidewire (Abbott) - K982083 cleared Sep 1998 4. Device Description Roll-XTm Guidewires are steerable guldewires constructed of a stainless steel… | 1998 |
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 21 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- None of the 18 ancestors has a recall.
- 1 other device also cites its predicate K082304.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
Roll-X Guidewires are intended to facilitate the placement of balloon dilation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The wires are also intended to facilitate the placement of compatible interventional devices during therapeutic intravascular procedures. The guidewires are not to be used in cerebral blood vessels.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100710 · printed Nov 3, 2026
Cite this page
510(k) Report. “K100710: Roll-X Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K100710
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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