510(k) · Cleared
ClearedScimed Sceptor Ptca Guide Wire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scimed Life Systems, Inc. · DQX Wire, Guide, Catheter
Cleared on Apr 28, 1995 after an 80-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Apr 28, 1995
- Review
- 80 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK950534 Scimed Sceptor Ptca Guide WireScimed Life Systems, Inc. · 1995
- Descendant · cites it directly · 2 of its ownK965023 Choice PT Plus Ptca Guide Wire and Choice PT Vision Ptca Guide WireScimed Life Systems, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK974241 Scimed Informer Pressure Wire SystemScimed Life Systems, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK980360 Scimed Quest Floppy and Moderate Support Guide WiresScimed Life Systems, Inc. · 1998
Most influential descendants
Showing 3 of 3 · See all- K965023Choice PT Plus Ptca Guide Wire and Choice PT Vision Ptca Guide WireScimed Life Systems, Inc. · 1997 · cites it directly2descendants
- K974241Scimed Informer Pressure Wire SystemScimed Life Systems, Inc. · 1998 · cites it directly0descendants
- K980360Scimed Quest Floppy and Moderate Support Guide WiresScimed Life Systems, 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) | K950534 | Scimed Sceptor Ptca Guide Wire | Scimed Life Systems, Inc. | 1995 | — |
| +1 | K965023 | Choice PT Plus Ptca Guide Wire and Choice PT Vision Ptca Guide Wire | Scimed Life Systems, Inc. | 1997 | — |
| +1 | K974241 | Scimed Informer Pressure Wire System | Scimed Life Systems, Inc. | 1998 | — |
| +1 | K980360 | Scimed Quest Floppy and Moderate Support Guide Wires | Scimed Life Systems, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
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, K965023 (Scimed Life Systems, Inc., 1997) has gone furthest, with 2 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) | — |
https://510kreport.com/device/K950534 · printed Nov 4, 2026
Cite this page
510(k) Report. “K950534: Scimed Sceptor Ptca 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/K950534
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026