510(k) · Cleared
ClearedEdwards eSheath Optima introducer set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edwards Lifesciences · DYB Introducer, Catheter
Cleared on Aug 29, 2025 as substantially equivalent to K244046 (Edwards Lifesciences, 2025) after a 31-day review. Its family tree reaches back 10 generations to 1993. 2 of the 18 devices in its family, counting itself, have a Class I recall.
- Decided
- Aug 29, 2025
- Review
- 31 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K924607 (1993). 17 ancestors in all, the oldest K902469 (1990). No later device cites it as a predicate yet. 2 of the 18 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK924607 Arrow Fischell Kink Resist Percut Sheath Intro SetArrow Intl., Inc. · 1993 · Recalled
- 6 generations between
- 3 generations backK162184 Edwards eSheath Introducer SetEdward Lifesciences · 2016
- 2 generations backK200258 Edwards eSheath Introducer SetEdwards Lifesciences · 2020
- 1 generation backK244046 Edwards eSheath Optima introducer setEdwards Lifesciences · 2025
- This deviceK252364 Edwards eSheath Optima introducer setEdwards Lifesciences · 2025
Show all 10 generations
- Root · 10 generations backK924607 Arrow Fischell Kink Resist Percut Sheath Intro SetArrow Intl., Inc. · 1993 · Recalled
- 9 generations backK012812 Carotid Guiding SheathTerumo Medical Corp. · 2001 · Recalled
- 8 generations backK051601 Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2005
- 7 generations backK080415 Device Modification to Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2008
- 6 generations backK091329 Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2009 · Recalled
- 5 generations backK142829 Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor…Cook Incorporated · 2015 · Recalled (Class I)
- 4 generations backK152225 Edwards eSheath Introducer SetEdwards Lifesciences · 2015
- 3 generations backK162184 Edwards eSheath Introducer SetEdward Lifesciences · 2016
- 2 generations backK200258 Edwards eSheath Introducer SetEdwards Lifesciences · 2020
- 1 generation backK244046 Edwards eSheath Optima introducer setEdwards Lifesciences · 2025
- This deviceK252364 Edwards eSheath Optima introducer setEdwards Lifesciences · 2025
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K924607 | Arrow Fischell Kink Resist Percut Sheath Intro Set | Arrow Intl., Inc. | 1993 | 3 |
| −9 | K012812 | Carotid Guiding Sheath | Terumo Medical Corp. | 2001 | 1 |
| −8 | K051601 | Pinnacle Destination Peripheral Guiding Sheath | Terumo Medical Corp. | 2005 | — |
| −7 | K080415 | Device Modification to Pinnacle Destination Peripheral Guiding Sheath | Terumo Medical Corp. | 2008 | — |
| −6 | K091329 | Pinnacle Destination Peripheral Guiding Sheath | Terumo Medical Corp. | 2009 | 1 |
| −5 | K142829 | Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo… | Cook Incorporated | 2015 | Class I |
| −4 | K152225 | Edwards eSheath Introducer Set | Edwards Lifesciences | 2015 | — |
| −3 | K162184 | Edwards eSheath Introducer Set | Edward Lifesciences | 2016 | — |
| −2 | K200258 | Edwards eSheath Introducer Set | Edwards Lifesciences | 2020 | — |
| −1 | K244046 | Edwards eSheath Optima introducer set | Edwards Lifesciences | 2025 | — |
| 0 (this device) | K252364 | Edwards eSheath Optima introducer set | Edwards Lifesciences | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 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.
2 devices in this family have 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 |
|---|---|---|---|
| * | K244046 | Edwards eSheath Optima introducer setSummary page 5…cation: Catheter, Introducer 21 CFR 870.1340, Product Code DYB Predicate Device: Edwards eSheath Optima Introducer Set, Model 14000ES14 (K244046) Device Description: The Edwards eSheath Optima introducer set (herein referred to as Optima set), model 14000ES16, consists of… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 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.
- K142829Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer, Ansel Modification…Cook Incorporated · 2015 · 4 generations back · ◆ on the line of descent in FIG. 121 Class I recalls
- K100819The Solopath Balloon Expandable Transfemoral IntroducerOnset Medical Corporation · 2010 · 4 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 32 years and passes through 5 companies; a new generation was cleared every 3.5 years on median.
- 6 of the 17 ancestors have a recall of any class; 2 have a Class I recall.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Edwards eSheath Optima introducer set is indicated for the introduction and removal of compatible devices used with Edwards transcatheter heart valves.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252364 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252364: Edwards eSheath Optima introducer set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252364
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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