510(k) · Cleared
Recalled · Class II · 2015Primewire Prestige Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Volcano Corporation · DQX Wire, Guide, Catheter
Cleared on Aug 1, 2011 as substantially equivalent to K100930 (Volcano Corporation, 2010) after a 74-day review. Its family tree reaches back 5 generations to 1982. 13 later devices descend from it. It has been recalled once.
- Decided
- Aug 1, 2011
- Review
- 74 days
- Class
- Class II
- Product code
- DQX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K823434 (1982). 15 ancestors in all. 13 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK823434 Mikro-Tip Catheter Pressure TransducerMillar Instruments, Inc. · 1982
- 4 generations backK965140 Cardiometrics Wavewire/Wavemap Pressure SystemCardio Metrics, Inc. · 1997
- 3 generations backK021219 Smartwire/Smartmap Pressure SystemJomed, Inc. · 2002
- 2 generations backK070487 Smartwire Pressure Guide Wire, Model 66XXVolcano Corporation · 2007
- 1 generation backK100930 Primewire Prestiage Pressure Guide Wire, Models 8185, 8185J, 8300…Volcano Corporation · 2010
- This deviceK111395 Primewire Prestige PlusVolcano Corporation · 2011
- Descendant · cites it directly · 12 of its ownK142598 Opto Wire and OptoMonitor SystemOpsens, Inc. · 2015
- Descendant · cites it directly · 7 of its ownK192340 OptoMonitorOpsens, Inc. · 2019
- Descendant · 2 generations on · 6 of its ownK193620 OptoMonitor 3Opsens, Inc. · 2020
- Descendant · 2 generations on · 6 of its ownK152991 OptoWire DeuxOpsens · 2016
- Descendant · 2 generations on · 5 of its ownK202943 OptoMonitor 3Opsens, Inc. · 2020
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K142598Opto Wire and OptoMonitor SystemOpsens, Inc. · 2015 · cites it directly12descendants
- K192340OptoMonitorOpsens, Inc. · 2019 · cites it directly7descendants
- K193620OptoMonitor 3Opsens, Inc. · 2020 · 2 generations on6descendants
- K152991OptoWire DeuxOpsens · 2016 · 2 generations on6descendants
- K202943OptoMonitor 3Opsens, Inc. · 2020 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K823434 | Mikro-Tip Catheter Pressure Transducer | Millar Instruments, Inc. | 1982 | — |
| −4 | K965140 | Cardiometrics Wavewire/Wavemap Pressure System | Cardio Metrics, Inc. | 1997 | — |
| −3 | K021219 | Smartwire/Smartmap Pressure System | Jomed, Inc. | 2002 | — |
| −2 | K070487 | Smartwire Pressure Guide Wire, Model 66XX | Volcano Corporation | 2007 | — |
| −1 | K100930 | Primewire Prestiage Pressure Guide Wire, Models 8185, 8185J, 8300, 8300J | Volcano Corporation | 2010 | — |
| 0 (this device) | K111395 | Primewire Prestige Plus | Volcano Corporation | 2011 | — |
| +1 | K142598 | Opto Wire and OptoMonitor System | Opsens, Inc. | 2015 | — |
| +1 | K192340 | OptoMonitor | Opsens, Inc. | 2019 | — |
| +2 | K193620 | OptoMonitor 3 | Opsens, Inc. | 2020 | — |
| +2 | K152991 | OptoWire Deux | Opsens | 2016 | — |
| +2 | K202943 | OptoMonitor 3 | Opsens, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K100930 | Primewire Prestiage Pressure Guide Wire, Models 8185, 8185J, 8300, 8300JSummary page 1…Pressure Guide Wire is substantially equivalent to the following: 51(k Nube Product Name Clearance Date K 100930 IPrimeWire PRESTIGE® Pressure Guide Wire April 30, 20 10 Device Description: The PrimeWire PRESTIGE®… | 2010 |
What descends from it? (13)
See all 134 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 4, 2015 | Class II | Z-1845-2015 | Labeling mix-ups | During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in accordance with the date of the relabeling and not in accordance with the original shelf life date at the time of manufacture |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K142598 (Opsens, Inc., 2015) has gone furthest, with 12 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. 2011, 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?
The PrimeWire PRESTIGE® Plus Pressure Guide Wire Device is indicated for use to measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111395 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111395: Primewire Prestige Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111395
Report an extraction error
Are you the manufacturer?
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