510(k) · Cleared
ClearedLocking Stylet 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Pacemaker Corp. · DQX Wire, Guide, Catheter
Cleared on May 20, 1997 after an 84-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- May 20, 1997
- Review
- 84 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK970690 Locking Stylet 2Cook Pacemaker Corp. · 1997
- Descendant · cites it directly · 1 of its ownK990713 Spectranetics Lead Locking Device (LLD) #1, #2, #3 ListerSpectranetics Corp. · 1999
- Descendant · cites it directly · 0 of its ownK170298 Liberator Beacon Tip Locking StyletCook Incorporated · 2017
- Descendant · 2 generations on · 0 of its ownK043401 Spectranetics LLD CS, Model 518-039Spectranetics Corp. · 2005
- Descendant · cites it directly · 0 of its ownK981061 Intravascular Retrieval DeviceMed Institute, Inc. · 1998
Most influential descendants
Showing 4 of 4 · See all- K990713Spectranetics Lead Locking Device (LLD) #1, #2, #3 ListerSpectranetics Corp. · 1999 · cites it directly1descendant
- K170298Liberator Beacon Tip Locking StyletCook Incorporated · 2017 · cites it directly0descendants
- K043401Spectranetics LLD CS, Model 518-039Spectranetics Corp. · 2005 · 2 generations on0descendants
- K981061Intravascular Retrieval DeviceMed Institute, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970690 | Locking Stylet 2 | Cook Pacemaker Corp. | 1997 | — |
| +1 | K990713 | Spectranetics Lead Locking Device (LLD) #1, #2, #3 Lister | Spectranetics Corp. | 1999 | — |
| +1 | K170298 | Liberator Beacon Tip Locking Stylet | Cook Incorporated | 2017 | — |
| +2 | K043401 | Spectranetics LLD CS, Model 518-039 | Spectranetics Corp. | 2005 | — |
| +1 | K981061 | Intravascular Retrieval Device | Med Institute, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2005 | 1 | 0 |
| 2017 | 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? (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 |
|---|---|---|---|
| * | — | Locking Wire Guide Stylet Named without a submission number |
What descends from it? (4)
3 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?
- Of its descendants, K990713 (Spectranetics Corp., 1999) has gone furthest, with 1 descendant 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?
The Locking Stylet 2 is intended for use during the percutaneous removal of cardiac leads, indwelling catheters and other foreign objects having a central lumen.
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/K970690 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970690: Locking Stylet 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970690
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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