510(k) · Cleared
ClearedGaleo Focus Guide Wire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotronik, Inc. · DQX Wire, Guide, Catheter
Cleared on Mar 2, 2005 as substantially equivalent to K982272 (Biotronik, Inc., 1999) and 1 other predicate after a 182-day review. Its family tree reaches back 4 generations to 1991.
- Decided
- Mar 2, 2005
- Review
- 182 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K913353 (1991). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK913353 Vascular Guide WireAdvanced Cardiovascular Systems, Inc. · 1991
- 3 generations backK971815 Asc Balance Middleweight Guide WireGuidant Corp. · 1997
- 2 generations backK973494 HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs…Guidant Corp. · 1997
- 1 generation backK982272 Galeo HS 014 Model 117 130, Galeo S 014 Model 115 488, Galeao M 014…Biotronik, Inc. · 1999
- This deviceK042373 Galeo Focus Guide WireBiotronik, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K913353 | Vascular Guide Wire | Advanced Cardiovascular Systems, Inc. | 1991 | — |
| −3 | K971815 | Asc Balance Middleweight Guide Wire | Guidant Corp. | 1997 | — |
| −2 | K973494 | HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs HI-Torque… | Guidant Corp. | 1997 | — |
| −1 | K982272 | Galeo HS 014 Model 117 130, Galeo S 014 Model 115 488, Galeao M 014 Model… | Biotronik, Inc. | 1999 | — |
| 0 (this device) | K042373 | Galeo Focus Guide Wire | Biotronik, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 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 |
|---|---|---|---|
| * | K982272 | Galeo HS 014 Model 117 130, Galeo S 014 Model 115 488, Galeao M 014 Model 114156, Galeo…Summary page 1…guide wire lumens during PTCA or other therapeutic or diagnostic procedures. The Galeo Focus guide wires are substantially equivalent to BIOTRONIK's GALEO Guide Wires (#4K982272, cleared 01-08-99) and Galeo Hydro Guide Wires (#1(001736, cleared 08-02-00). The Galeo, Focus Guide Wires are identical in desig… | 1999 |
| * | K001736 | Galeo Hydro and Galeo Hydro J-TipSummary page 1…ostic procedures. The Galeo Focus guide wires are substantially equivalent to BIOTRONIK's GALEO Guide Wires (#4K982272, cleared 01-08-99) and Galeo Hydro Guide Wires (#1(001736, cleared 08-02-00). The Galeo, Focus Guide Wires are identical in design and materials and functionally equivalent to the Galeo a… | 2000 |
| † | K994358 | Atw Marker Wire Steerable Guidewire | 2000 |
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 14 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
- None of the 8 ancestors has a recall.
- 1 other device also cites its predicate K982272.
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?
Galeo coronary guide wires are indicated to facilitate the placement of balloon dilation catheters or other interventional devices with compatible guide wire lumen during an interventional procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042373 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042373: Galeo Focus Guide Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042373
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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