510(k) · Cleared
ClearedPrimewire Prestiage Pressure Guide Wire, Models 8185, 8185J, 8300, 8300J
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 Apr 30, 2010 as substantially equivalent to K021219 (Jomed, Inc., 2002) and 1 other predicate after a 25-day review. Its family tree reaches back 4 generations to 1982. 14 later devices descend from it.
- Decided
- Apr 30, 2010
- Review
- 25 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K823434 (1982). 14 ancestors in all. 14 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK823434 Mikro-Tip Catheter Pressure TransducerMillar Instruments, Inc. · 1982
- 3 generations backK965140 Cardiometrics Wavewire/Wavemap Pressure SystemCardio Metrics, Inc. · 1997
- 2 generations backK021219 Smartwire/Smartmap Pressure SystemJomed, Inc. · 2002
- 1 generation backK070487 Smartwire Pressure Guide Wire, Model 66XXVolcano Corporation · 2007
- This deviceK100930 Primewire Prestiage Pressure Guide Wire, Models 8185, 8185J, 8300…Volcano Corporation · 2010
- Descendant · cites it directly · 13 of its ownK111395 Primewire Prestige PlusVolcano Corporation · 2011 · Recalled
- Descendant · 2 generations on · 12 of its ownK142598 Opto Wire and OptoMonitor SystemOpsens, Inc. · 2015
- Descendant · 2 generations on · 7 of its ownK192340 OptoMonitorOpsens, Inc. · 2019
- Descendant · 3 generations on · 6 of its ownK193620 OptoMonitor 3Opsens, Inc. · 2020
- Descendant · 3 generations on · 6 of its ownK152991 OptoWire DeuxOpsens · 2016
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K111395Primewire Prestige PlusVolcano Corporation · 2011 · cites it directly13descendants
- K142598Opto Wire and OptoMonitor SystemOpsens, Inc. · 2015 · 2 generations on12descendants
- K192340OptoMonitorOpsens, Inc. · 2019 · 2 generations on7descendants
- K193620OptoMonitor 3Opsens, Inc. · 2020 · 3 generations on6descendants
- K152991OptoWire DeuxOpsens · 2016 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K823434 | Mikro-Tip Catheter Pressure Transducer | Millar Instruments, Inc. | 1982 | — |
| −3 | K965140 | Cardiometrics Wavewire/Wavemap Pressure System | Cardio Metrics, Inc. | 1997 | — |
| −2 | K021219 | Smartwire/Smartmap Pressure System | Jomed, Inc. | 2002 | — |
| −1 | K070487 | Smartwire Pressure Guide Wire, Model 66XX | Volcano Corporation | 2007 | — |
| 0 (this device) | K100930 | Primewire Prestiage Pressure Guide Wire, Models 8185, 8185J, 8300, 8300J | Volcano Corporation | 2010 | — |
| +1 | K111395 | Primewire Prestige Plus | Volcano Corporation | 2011 | 1 |
| +2 | K142598 | Opto Wire and OptoMonitor System | Opsens, Inc. | 2015 | — |
| +2 | K192340 | OptoMonitor | Opsens, Inc. | 2019 | — |
| +3 | K193620 | OptoMonitor 3 | Opsens, Inc. | 2020 | — |
| +3 | K152991 | OptoWire Deux | Opsens | 2016 | — |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 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? (4)
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 |
|---|---|---|---|
| * | K021219 | Smartwire/Smartmap Pressure System Our reading of the summary gave K021209, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “SmartWire/SmartMap Pressure System”. | 2002 |
| * | K070487 | Smartwire Pressure Guide Wire, Model 66XXSummary page 1…k) Number Product Name Clearance Date K02 1209 SmartWire/SmartMap Pressure System May 17, 2002 K070487 SmartWire II Pressure Guide Wire March 16, 2007 Letter to File PrimeWire Pressure Guide Wi… | 2007 |
| * | — | PrimeWire Pressure Guide Wire (June 26, 2008) Named without a submission number | |
| * | — | PrimeWire Pressure Guide Wire (April 6, 2009) Named without a submission number |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111395 | Primewire Prestige Plus | 2011 | 13 |
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 28 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K111395 (Volcano Corporation, 2011) has gone furthest, with 13 descendants of its own.
- 5 other devices also cite its predicate K021219.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 TMPressure 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/K100930 · printed Nov 3, 2026
Cite this page
510(k) Report. “K100930: Primewire Prestiage Pressure Guide Wire, Models 8185, 8185J, 8300, 8300J.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K100930
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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