510(k) · Cleared
Recalled · Class II · 2022OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip
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 Sep 28, 2020 as substantially equivalent to K192886 (Volcano Corporation, 2020) after a 26-day review. Its family tree reaches back 3 generations to 2013. It has been recalled once.
- Decided
- Sep 28, 2020
- Review
- 26 days
- Class
- Class II
- Product code
- DQX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K131288 (2013). No later device cites it as a predicate yet.
- Root · 3 generations backK131288 Verrata Pressure Guide WireVolcano Corporation · 2013
- 2 generations backK161887 Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS…Volcano Corporation · 2016
- 1 generation backK192886 OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure…Volcano Corporation · 2020
- This deviceK202543 OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure…Volcano Corporation · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K131288 | Verrata Pressure Guide Wire | Volcano Corporation | 2013 | — |
| −2 | K161887 | Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure… | Volcano Corporation | 2016 | — |
| −1 | K192886 | OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide… | Volcano Corporation | 2020 | — |
| 0 (this device) | K202543 | OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide… | Volcano Corporation | 2020 | — |
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 |
|---|---|---|---|
| * | K192886 | OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm…Summary page 4…re, Guide, Catheter Number and Name: 870.2870 Catheter Tip Pressure Transducer Device Class: II Predicate Device: OmniWire Pressure Guide Wire (K192886) Device Description: The OmniWire pressure guide wire is a steerable guide wire with a pressure sensor… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 16, 2022 | Class II | Z-1270-2022 | Under Investigation by firm | Due to a potential failed sterilization process. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 1 company; a new generation was cleared every 3.2 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 OmniWire pressure guide wire is indicated for use to measure pressure in blood vessels, including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. It can also be used to facilitate the placement of catheters as well as other interventional devices in coronary and peripheral vessels. 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/K202543 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202543: OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202543
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