510(k) · Cleared
ClearedEndophys Blood Pressure Monitor model BPM-30
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endophys Technologies, LLC · DSK Computer, Blood-Pressure
Cleared on Nov 3, 2023 as substantially equivalent to K160945 (Endophys Holdings, LLC, 2016) after a 156-day review. Its family tree reaches back 9 generations to 2001.
- Decided
- Nov 3, 2023
- Review
- 156 days
- Class
- Class II
- Product code
- DSK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K003122 (2001). 18 ancestors in all, the oldest K002067 (2001). No later device cites it as a predicate yet.
- Root · 9 generations backK003122 Smartflow, Model Sfip 2000Florence Medical, Ltd. · 2001
- 5 generations between
- 3 generations backK132474 Cardiovascular Pressure Measurement (CPM) System, Navvus CatheterAcist Medical Systems · 2014
- 2 generations backK141615 Endophys Blood Pressure MonitorEndophys, Inc. · 2015
- 1 generation backK160945 Endophys Blood Pressure MonitorEndophys Holdings, LLC · 2016
- This deviceK231586 Endophys Blood Pressure Monitor model BPM-30Endophys Technologies, LLC · 2023
Show all 9 generations
- Root · 9 generations backK003122 Smartflow, Model Sfip 2000Florence Medical, Ltd. · 2001
- 8 generations backK012947 SmartflowFlorence Medical, Ltd. · 2001
- 7 generations backK020127 Smartflow Pulse Transmission CoefficientFlorence Medical, Ltd. · 2002
- 6 generations backK022188 Radianalyzer, Model 12710Radi Medical Systems AB · 2002
- 5 generations backK031662 Pressure Wire Sensor, Models 12004/12304Radi Medical Systems AB · 2003
- 4 generations backK062769 Pressurewire Certus, Models 12006 and 12306Radi Medical Systems AB · 2006
- 3 generations backK132474 Cardiovascular Pressure Measurement (CPM) System, Navvus CatheterAcist Medical Systems · 2014
- 2 generations backK141615 Endophys Blood Pressure MonitorEndophys, Inc. · 2015
- 1 generation backK160945 Endophys Blood Pressure MonitorEndophys Holdings, LLC · 2016
- This deviceK231586 Endophys Blood Pressure Monitor model BPM-30Endophys Technologies, LLC · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K003122 | Smartflow, Model Sfip 2000 | Florence Medical, Ltd. | 2001 | — |
| −8 | K012947 | Smartflow | Florence Medical, Ltd. | 2001 | — |
| −7 | K020127 | Smartflow Pulse Transmission Coefficient | Florence Medical, Ltd. | 2002 | — |
| −6 | K022188 | Radianalyzer, Model 12710 | Radi Medical Systems AB | 2002 | — |
| −5 | K031662 | Pressure Wire Sensor, Models 12004/12304 | Radi Medical Systems AB | 2003 | — |
| −4 | K062769 | Pressurewire Certus, Models 12006 and 12306 | Radi Medical Systems AB | 2006 | — |
| −3 | K132474 | Cardiovascular Pressure Measurement (CPM) System, Navvus Catheter | Acist Medical Systems | 2014 | — |
| −2 | K141615 | Endophys Blood Pressure Monitor | Endophys, Inc. | 2015 | — |
| −1 | K160945 | Endophys Blood Pressure Monitor | Endophys Holdings, LLC | 2016 | — |
| 0 (this device) | K231586 | Endophys Blood Pressure Monitor model BPM-30 | Endophys Technologies, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 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 DSK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K160945 | Endophys Blood Pressure MonitorSummary page 4…ly marketed Endophys Blood Pressure Monitor model BPM-20 (K160945) Endophys 510(k) Summary Page 1 of 4 K231586 - Traditional 510(k): Endophys Blo… | 2016 |
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 22 years and passes through 6 companies; a new generation was cleared every 11 months on median.
- None of the 18 ancestors has a recall.
How does its category compare?
All DSK devicesDSK Computer, Blood-Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · DSK
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · DSK
Too few DSK 510(k)s in any year since 2007 to give a median.
Recalls per year · DSK
No recall names DSK since 2007.
Adverse event reports per year · DSK
26in 2025
MAUDE reports naming product code DSK, 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 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 10 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 69 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 0 | — | 0 | 8 |
| 2015 | 2 | — | 0 | 7 |
| 2016 | 1 | — | 0 | 13 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 93 |
| 2019 | 0 | — | 0 | 148 |
| 2020 | 0 | — | 0 | 29 |
| 2021 | 0 | — | 0 | 31 |
| 2022 | 0 | — | 0 | 29 |
| 2023 | 1 | — | 0 | 14 |
| 2024 | 0 | — | 0 | 12 |
| 2025 | 0 | — | 0 | 26 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Endophys Blood Pressure Monitor Model BPM-30 is intended to continuously provide systolic, diastolic and mean blood pressure based on the output of the Endophys PSS3 Pressure Sensing Sheath in patients undergoing therapeutic and/or diagnostic procedures involving percutaneous vascular access. The Endophys Blood Pressure Monitor Model BPM-30 monitor is additionally intended for use in transport situations within hospital environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231586 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231586: Endophys Blood Pressure Monitor model BPM-30.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231586
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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