510(k) · Cleared
ClearedComet II Pressure Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · DXO Transducer, Pressure, Catheter Tip
Cleared on Dec 23, 2019 as substantially equivalent to K151610 (Boston Scientific Corporation, 2015) after a 26-day review. Its family tree reaches back 10 generations to 2001.
- Decided
- Dec 23, 2019
- Review
- 26 days
- Class
- Class II
- Product code
- DXO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K003122 (2001). 20 ancestors in all, the oldest K883651 (1988). No later device cites it as a predicate yet.
- Root · 10 generations backK003122 Smartflow, Model Sfip 2000Florence Medical, Ltd. · 2001
- 6 generations between
- 3 generations backK113584 Pressurewire Certus, Certus 300, Aeris, Aeris 300, and ReceiverSt Jude Medical · 2012
- 2 generations backK131452 Pressurewire; Certus, Certus 300, Aeris, Aeris 300St. Jude Medical Systems AB · 2013
- 1 generation backK151610 Comet Pressure GuidewireBoston Scientific Corporation · 2015
- This deviceK193279 Comet II Pressure GuidewireBoston Scientific Corporation · 2019
Show all 10 generations
- Root · 10 generations backK003122 Smartflow, Model Sfip 2000Florence Medical, Ltd. · 2001
- 9 generations backK012947 SmartflowFlorence Medical, Ltd. · 2001
- 8 generations backK020127 Smartflow Pulse Transmission CoefficientFlorence Medical, Ltd. · 2002
- 7 generations backK022188 Radianalyzer, Model 12710Radi Medical Systems AB · 2002
- 6 generations backK031662 Pressure Wire Sensor, Models 12004/12304Radi Medical Systems AB · 2003
- 5 generations backK062769 Pressurewire Certus, Models 12006 and 12306Radi Medical Systems AB · 2006
- 4 generations backK080813 Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), ReceiverRadi Medical Systems AB · 2008
- 3 generations backK113584 Pressurewire Certus, Certus 300, Aeris, Aeris 300, and ReceiverSt Jude Medical · 2012
- 2 generations backK131452 Pressurewire; Certus, Certus 300, Aeris, Aeris 300St. Jude Medical Systems AB · 2013
- 1 generation backK151610 Comet Pressure GuidewireBoston Scientific Corporation · 2015
- This deviceK193279 Comet II Pressure GuidewireBoston Scientific Corporation · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K003122 | Smartflow, Model Sfip 2000 | Florence Medical, Ltd. | 2001 | — |
| −9 | K012947 | Smartflow | Florence Medical, Ltd. | 2001 | — |
| −8 | K020127 | Smartflow Pulse Transmission Coefficient | Florence Medical, Ltd. | 2002 | — |
| −7 | K022188 | Radianalyzer, Model 12710 | Radi Medical Systems AB | 2002 | — |
| −6 | K031662 | Pressure Wire Sensor, Models 12004/12304 | Radi Medical Systems AB | 2003 | — |
| −5 | K062769 | Pressurewire Certus, Models 12006 and 12306 | Radi Medical Systems AB | 2006 | — |
| −4 | K080813 | Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), Receiver | Radi Medical Systems AB | 2008 | — |
| −3 | K113584 | Pressurewire Certus, Certus 300, Aeris, Aeris 300, and Receiver | St Jude Medical | 2012 | — |
| −2 | K131452 | Pressurewire; Certus, Certus 300, Aeris, Aeris 300 | St. Jude Medical Systems AB | 2013 | — |
| −1 | K151610 | Comet Pressure Guidewire | Boston Scientific Corporation | 2015 | — |
| 0 (this device) | K193279 | Comet II Pressure Guidewire | Boston Scientific Corporation | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 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 DXO? 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 DXO device
- #1 K241418 OptoMonitor 3score 14.8 · 11 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 |
|---|---|---|---|
| * | K151610 | Comet Pressure GuidewireSummary page 4…Transducer, Pressure, Catheter Tip Product Code DXO, DQX Classification Class II, 21 CFR Part 870. 2870 Predicate Device CometTM Pressure Guidewire K151610 October 6, 2019 K193279 Page 1 of 3… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 18 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- None of the 20 ancestors has a recall.
How does its category compare?
All DXO devicesDXO Transducer, Pressure, Catheter Tip: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · DXO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXO
120in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXO
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXO
183in 2025
MAUDE reports naming product code DXO, 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 | 1 | — | 0 | 3 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 8 |
| 2010 | 1 | — | 0 | 74 |
| 2011 | 1 | — | 0 | 111 |
| 2012 | 1 | — | 0 | 82 |
| 2013 | 1 | — | 0 | 93 |
| 2014 | 3 | 176 | 0 | 85 |
| 2015 | 2 | — | 1 | 114 |
| 2016 | 2 | — | 0 | 152 |
| 2017 | 2 | — | 0 | 186 |
| 2018 | 1 | — | 0 | 179 |
| 2019 | 4 | 120 | 0 | 153 |
| 2020 | 2 | — | 0 | 158 |
| 2021 | 0 | — | 0 | 116 |
| 2022 | 1 | — | 0 | 144 |
| 2023 | 0 | — | 0 | 194 |
| 2024 | 1 | — | 0 | 197 |
| 2025 | 1 | — | 0 | 183 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Comet II Pressure Guidewire is indicated to direct a catheter through a blood vessel and measure physiological parameters in the coronary and peripheral blood vessels.
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/K193279 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193279: Comet II Pressure Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193279
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