510(k) · Cleared
ClearedPtca 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 Jun 6, 1997 after a 123-day review. The FDA summary names no predicate by number. 5 of the 88 devices in its family, counting itself, have a Class I recall. 87 later devices descend from it.
- Decided
- Jun 6, 1997
- Review
- 123 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 0
87 later devices descend from it, 7 citing it directly. 5 of the 88 devices in this family, counting this one, have a Class I recall.
- This deviceK970376 Ptca GuidewireLake Region Mfg., Inc. · 1997
- Descendant · cites it directly · 70 of its ownK011968 Streerable Ptca GuidewireLake Region Mfg., Inc. · 2001 · Recalled
- Descendant · cites it directly · 49 of its ownK022813 Steerable GuidewireLake Region Mfg., Inc. · 2003
- Descendant · 2 generations on · 36 of its ownK042338 Coronary Peripheral and Renal Steerable GuidewireLake Region Mfg., Inc. · 2004
- Descendant · 3 generations on · 35 of its ownK062192 Ostial Pro Stent Positioning SystemOstial Solutions, LLC · 2007
- Descendant · 4 generations on · 30 of its ownK083745 The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009
Showing 5 of 87 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K190106 Intra-Operative Positioning System; Simple Curve…7 generations on · 2019
- K242133 Intra-Operative Positioning System (IOPS®)…8 generations on · 2024
- K241243 Intra-Operative Positioning System (IOPS®)…8 generations on · 2024
- K230309 Intra-Operative Positioning System (IOPS®)…8 generations on · 2023
Most influential descendants
Showing 5 of 87 · See all- K011968Streerable Ptca GuidewireLake Region Mfg., Inc. · 2001 · cites it directly70descendants
- K022813Steerable GuidewireLake Region Mfg., Inc. · 2003 · cites it directly49descendants
- K042338Coronary Peripheral and Renal Steerable GuidewireLake Region Mfg., Inc. · 2004 · 2 generations on36descendants
- K062192Ostial Pro Stent Positioning SystemOstial Solutions, LLC · 2007 · 3 generations on35descendants
- K083745The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009 · 4 generations on30descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970376 | Ptca Guidewire | Lake Region Mfg., Inc. | 1997 | — |
| +1 | K011968 | Streerable Ptca Guidewire | Lake Region Mfg., Inc. | 2001 | 2 |
| +1 | K022813 | Steerable Guidewire | Lake Region Mfg., Inc. | 2003 | — |
| +2 | K042338 | Coronary Peripheral and Renal Steerable Guidewire | Lake Region Mfg., Inc. | 2004 | — |
| +3 | K062192 | Ostial Pro Stent Positioning System | Ostial Solutions, LLC | 2007 | — |
| +4 | K083745 | The IC-Pro System, Model Version 3.2 | Paieon, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 5 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2012 | 11 | 0 |
| 2013 | 1 | 0 |
| 2014 | 5 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 1 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 5 | 1 |
| 2024 | 3 | 2 |
| 2025 | 4 | 1 |
| 2026 | 5 | 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.
5 devices in this family have a Class I recall. 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?
The FDA summary names no predicate by number.
What descends from it? (87)
See all 877 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K011968 | Streerable Ptca Guidewire | 2001 | 70 |
| K022813 | Steerable Guidewire | 2003 | 49 |
| K081187 | Bridgepoint Medical Entera Percutaneous Coronary and Peripheral Guidewire, Model M-3001 | 2008 | 13 |
| K030617 | PT2 Guide Wire and Addwire Extension Wire | 2003 | 11 |
| K041624 | Ptca Steerable Hydrophilic Guidewire | 2004 | 4 |
| K014210 | Palmo Thermoregulation Interface Accessory | 2002 | 1 |
| K082922 | Freeway and Railrunner Guidewires | 2008 | 0 |
Has anything in its family been recalled? (5 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire…Centerline Biomedical, Inc. · 2019 · 7 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
- K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System…Centerline Biomedical, Inc. · 2024 · 8 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
- K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning…Centerline Biomedical, Inc. · 2024 · 8 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
- K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve…Centerline Biomedical, Inc. · 2023 · 8 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · 8 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K011968 (Lake Region Mfg., Inc., 2001) has gone furthest, with 70 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?
Lake Region’s steerable quidewires are 1intended for wuse in angiographic procedures to introduce and position catheters and interventional devices within the <coronary and peripheral vasculature.
The attachment of the guidewire extension to the Lake Region Steerable guidewire creates a gquidewire that can be used to exchange a catheter without removing the guidewire from the vessel. When the exchange is complete, the guidewire extension can be detached and the original guidewire can again be used in a conventional manner.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970376 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970376: Ptca Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970376
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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