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, Inc. · DYB Introducer, Catheter
Cleared on Jan 7, 2015 as substantially equivalent to K052557 (Togo Medikit Co., Ltd., 2006) and 3 other predicates after a 236-day review. Its family tree reaches back 7 generations to 2001. 1 of the 32 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.
- Decided
- Jan 7, 2015
- Review
- 236 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K003122 (2001). 27 ancestors in all, the oldest K792177 (1979). 4 later devices descend from it, 1 citing it directly. 1 of the 32 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK003122 Smartflow, Model Sfip 2000Florence Medical, Ltd. · 2001
- 6 generations backK012947 SmartflowFlorence Medical, Ltd. · 2001
- 5 generations backK020127 Smartflow Pulse Transmission CoefficientFlorence Medical, Ltd. · 2002
- 4 generations backK022188 Radianalyzer, Model 12710Radi Medical Systems AB · 2002
- 3 generations backK031662 Pressure Wire Sensor, Models 12004/12304Radi Medical Systems AB · 2003
- 2 generations backK062769 Pressurewire Certus, Models 12006 and 12306Radi Medical Systems AB · 2006
- 1 generation backK132474 Cardiovascular Pressure Measurement (CPM) System, Navvus CatheterAcist Medical Systems · 2014
- This deviceK141275 Endophys Pressure Sensing Sheath KitEndophys, Inc. · 2015
- Descendant · cites it directly · 3 of its ownK160272 Endophys Pressure Sensing Sheath KitEndophys, Inc. · 2016
- Descendant · 2 generations on · 1 of its ownK173399 Endophys Pressure Sensing Sheath Kit- 8FEndophys Holdings, LLC · 2017
- Descendant · 3 generations on · 0 of its ownK190098 Endophys Pressure Sensing SheathEndophys Holdings, LLC · 2019
- Descendant · 2 generations on · 0 of its ownK180620 Endophys Pressure Sensing Sheath KitEndophys Holdings, LLC · 2018
Class I recalls in this family
- K120212 Afx Introducer Systemdirect predicate · 2012
Most influential descendants
Showing 4 of 4 · See all- K160272Endophys Pressure Sensing Sheath KitEndophys, Inc. · 2016 · cites it directly3descendants
- K173399Endophys Pressure Sensing Sheath Kit- 8FEndophys Holdings, LLC · 2017 · 2 generations on1descendant
- K190098Endophys Pressure Sensing SheathEndophys Holdings, LLC · 2019 · 3 generations on0descendants
- K180620Endophys Pressure Sensing Sheath KitEndophys Holdings, LLC · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K003122 | Smartflow, Model Sfip 2000 | Florence Medical, Ltd. | 2001 | — |
| −6 | K012947 | Smartflow | Florence Medical, Ltd. | 2001 | — |
| −5 | K020127 | Smartflow Pulse Transmission Coefficient | Florence Medical, Ltd. | 2002 | — |
| −4 | K022188 | Radianalyzer, Model 12710 | Radi Medical Systems AB | 2002 | — |
| −3 | K031662 | Pressure Wire Sensor, Models 12004/12304 | Radi Medical Systems AB | 2003 | — |
| −2 | K062769 | Pressurewire Certus, Models 12006 and 12306 | Radi Medical Systems AB | 2006 | — |
| −1 | K132474 | Cardiovascular Pressure Measurement (CPM) System, Navvus Catheter | Acist Medical Systems | 2014 | — |
| 0 (this device) | K141275 | Endophys Pressure Sensing Sheath Kit | Endophys, Inc. | 2015 | — |
| +1 | K160272 | Endophys Pressure Sensing Sheath Kit | Endophys, Inc. | 2016 | — |
| +2 | K173399 | Endophys Pressure Sensing Sheath Kit- 8F | Endophys Holdings, LLC | 2017 | — |
| +3 | K190098 | Endophys Pressure Sensing Sheath | Endophys Holdings, LLC | 2019 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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.
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? (4)
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 |
|---|---|---|---|
| * | K052557 | Super Sheath Introducer SheathSummary page 4…Product Code: DYB, Catheter Introducer, DXO, Transducer, Pressure, Catheter tip PREDICATE DEVICES x Togo Medikit Co., Ltd. Super Sheath Introducer Sheath (K052557) x Endologix AFX Introducer System (K120212) x Millar Instruments, Inc. Mikro-Cath (K093111) x Acist Medical… | 2006 |
| * | K120212 | Afx Introducer SystemSummary page 4…Transducer, Pressure, Catheter tip PREDICATE DEVICES x Togo Medikit Co., Ltd. Super Sheath Introducer Sheath (K052557) x Endologix AFX Introducer System (K120212) x Millar Instruments, Inc. Mikro-Cath (K093111) x Acist Medical Systems Rapid Exchange (RXi) System and Navvus Cat… | 2012 |
| * | K093111 | Mikro-Cath, Model 825-0101Summary page 4…x Togo Medikit Co., Ltd. Super Sheath Introducer Sheath (K052557) x Endologix AFX Introducer System (K120212) x Millar Instruments, Inc. Mikro-Cath (K093111) x Acist Medical Systems Rapid Exchange (RXi) System and Navvus Catheter (K132474)… | 2010 |
| * | K132474 | Cardiovascular Pressure Measurement (CPM) System, Navvus CatheterSummary page 4…troducer System (K120212) x Millar Instruments, Inc. Mikro-Cath (K093111) x Acist Medical Systems Rapid Exchange (RXi) System and Navvus Catheter (K132474) 2 510(k) SUMMARY… | 2014 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160272 | Endophys Pressure Sensing Sheath Kit | 2016 | 3 |
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 · Direct predicate · ◆ in the 2012 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 8 months on median.
- 5 of the 27 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K160272 (Endophys, Inc., 2016) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K052557.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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.
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/K141275 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141275: Endophys Pressure Sensing Sheath Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141275
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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