510(k) · Cleared
ClearedEndophys Pressure Sensing Sheath Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endophys Holdings, LLC · DYB Introducer, Catheter
Cleared on Oct 12, 2018 as substantially equivalent to K160272 (Endophys, Inc., 2016) after a 217-day review. Its family tree reaches back 9 generations to 2001. 1 of the 30 devices in its family, counting itself, has a Class I recall.
- Decided
- Oct 12, 2018
- Review
- 217 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K003122 (2001). 29 ancestors in all, the oldest K792177 (1979). No later device cites it as a predicate yet. 1 of the 30 devices in this family, counting this one, has a Class I recall.
- 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 backK141275 Endophys Pressure Sensing Sheath KitEndophys, Inc. · 2015
- 1 generation backK160272 Endophys Pressure Sensing Sheath KitEndophys, Inc. · 2016
- This deviceK180620 Endophys Pressure Sensing Sheath KitEndophys Holdings, LLC · 2018
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 backK141275 Endophys Pressure Sensing Sheath KitEndophys, Inc. · 2015
- 1 generation backK160272 Endophys Pressure Sensing Sheath KitEndophys, Inc. · 2016
- This deviceK180620 Endophys Pressure Sensing Sheath KitEndophys Holdings, LLC · 2018
Class I recalls in this family
- K120212 Afx Introducer System3 generations back · 2012
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 | K141275 | Endophys Pressure Sensing Sheath Kit | Endophys, Inc. | 2015 | — |
| −1 | K160272 | Endophys Pressure Sensing Sheath Kit | Endophys, Inc. | 2016 | — |
| 0 (this device) | K180620 | Endophys Pressure Sensing Sheath Kit | Endophys Holdings, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 1 |
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.
1 device in this family has a Class I recall. 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 DYB device
- #1 K251051 AuST Steerable Sheathscore 18.0 · 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 |
|---|---|---|---|
| * | K160272 | Endophys Pressure Sensing Sheath KitSummary page 4…er Introducer Regulatory Class: 2 Product Code: DYB (classification); DXO (subsequent) III. PREDICATE DEVICE Endophys Pressure Sensing Sheath Kit (K160272) This predicate has not been subject to a design-related recall No reference devices were used in this submission.… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K120212Afx Introducer SystemEndologix, Inc. · 2012 · 3 generations back · ◆ in the 2012 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 17 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 5 of the 29 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K160272.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · DYB
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DYB
63in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DYB
3in 2025
Class I (48 since 2007) Class II/III not classified
Adverse event reports per year · DYB
4,539in 2025
MAUDE reports naming product code DYB, 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 | 12 | 95 | 15 | 316 |
| 2008 | 17 | 37 | 9 | 423 |
| 2009 | 14 | 52 | 25 | 399 |
| 2010 | 18 | 123 | 18 | 445 |
| 2011 | 17 | 100 | 4 | 628 |
| 2012 | 22 | 128 | 3 | 898 |
| 2013 | 26 | 118 | 5 (1) | 743 |
| 2014 | 30 | 122 | 2 | 780 |
| 2015 | 17 | 129 | 2 (1) | 913 |
| 2016 | 19 | 95 | 45 (3) | 1,234 |
| 2017 | 24 | 70 | 22 (1) | 1,672 |
| 2018 | 19 | 156 | 1 | 1,903 |
| 2019 | 18 | 47 | 2 | 2,450 |
| 2020 | 9 | 49 | 21 (21) | 2,465 |
| 2021 | 12 | 78 | 6 | 2,835 |
| 2022 | 13 | 143 | 2 | 4,084 |
| 2023 | 15 | 55 | 10 | 3,775 |
| 2024 | 18 | 56 | 2 | 3,931 |
| 2025 | 16 | 63 | 3 | 4,539 |
| 2026 | 17 | 59 | 23 (21) | — |
What is it indicated for?
The Endophys Pressure Sensing Sheath Kit (Endophys Pressure Sensing Sheath, vessel dilator and guidewire) is intended
to facilitate the introduction of diagnostic and interventional devices into the vasculature and to continuously measure
blood pressure during the procedure when used with the Endophys Blood Pressure Monitor.
Together, the Pressure Sensing Sheath and the Blood Pressure Monitor comprise the Endophys Pressure Sensing Access
System (PSAS™),
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/K180620 · printed Nov 5, 2026
Cite this page
510(k) Report. “K180620: Endophys Pressure Sensing Sheath Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180620
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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