510(k) · Cleared
ClearedEndophys Blood Pressure Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endophys Holdings, LLC · DSK Computer, Blood-Pressure
Cleared on Sep 26, 2016 as substantially equivalent to K141615 (Endophys, Inc., 2015) after a 174-day review. Its family tree reaches back 8 generations to 2001. 1 later device descends from it.
- Decided
- Sep 26, 2016
- Review
- 174 days
- Class
- Class II
- Product code
- DSK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K003122 (2001). 17 ancestors in all, the oldest K002067 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK003122 Smartflow, Model Sfip 2000Florence Medical, Ltd. · 2001
- 7 generations backK012947 SmartflowFlorence Medical, Ltd. · 2001
- 6 generations backK020127 Smartflow Pulse Transmission CoefficientFlorence Medical, Ltd. · 2002
- 5 generations backK022188 Radianalyzer, Model 12710Radi Medical Systems AB · 2002
- 4 generations backK031662 Pressure Wire Sensor, Models 12004/12304Radi Medical Systems AB · 2003
- 3 generations backK062769 Pressurewire Certus, Models 12006 and 12306Radi Medical Systems AB · 2006
- 2 generations backK132474 Cardiovascular Pressure Measurement (CPM) System, Navvus CatheterAcist Medical Systems · 2014
- 1 generation backK141615 Endophys Blood Pressure MonitorEndophys, Inc. · 2015
- This deviceK160945 Endophys Blood Pressure MonitorEndophys Holdings, LLC · 2016
- Descendant · cites it directly · 0 of its ownK231586 Endophys Blood Pressure Monitor model BPM-30Endophys Technologies, LLC · 2023
Most influential descendants
Showing 1 of 1 · See all- K231586Endophys Blood Pressure Monitor model BPM-30Endophys Technologies, LLC · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K003122 | Smartflow, Model Sfip 2000 | Florence Medical, Ltd. | 2001 | — |
| −7 | K012947 | Smartflow | Florence Medical, Ltd. | 2001 | — |
| −6 | K020127 | Smartflow Pulse Transmission Coefficient | Florence Medical, Ltd. | 2002 | — |
| −5 | K022188 | Radianalyzer, Model 12710 | Radi Medical Systems AB | 2002 | — |
| −4 | K031662 | Pressure Wire Sensor, Models 12004/12304 | Radi Medical Systems AB | 2003 | — |
| −3 | K062769 | Pressurewire Certus, Models 12006 and 12306 | Radi Medical Systems AB | 2006 | — |
| −2 | K132474 | Cardiovascular Pressure Measurement (CPM) System, Navvus Catheter | Acist Medical Systems | 2014 | — |
| −1 | K141615 | Endophys Blood Pressure Monitor | Endophys, Inc. | 2015 | — |
| 0 (this device) | K160945 | Endophys Blood Pressure Monitor | Endophys Holdings, LLC | 2016 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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.
Top candidate predicates for a new DSK device
- #1 K231586 Endophys Blood Pressure Monitor model BPM-30score 8.7 · 9 generations · no Class I recall
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 |
|---|---|---|---|
| * | K141615 | Endophys Blood Pressure MonitorSummary page 4…uter, Blood Pressure Regulatory Class: 2 Product Code: DSK III. PREDICATE DEVICE Endophys Blood Pressure Monitor (K141615) This predicate has not been subject to a design-related recall IntelliVue Patient Monitors MX400,… | 2015 |
| † | K141015 | Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231586 | Endophys Blood Pressure Monitor model BPM-30 | 2023 | 0 |
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 15 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- None of the 17 ancestors has a recall.
- Of its descendants, K231586 (Endophys Technologies, LLC, 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DSK devicesDSK Computer, Blood-Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 651 is intended for use in a catheterization laboratory to continuously provide systolic, diastolic and mean blood pressure based on the output of the Endophys Pressure Sensing Sheath in patients undergoing therapeutic and/or diagnostic procedures involving percutaneous vascular access.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160945 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160945: Endophys Blood Pressure Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160945
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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