510(k) · Cleared
ClearedEdwards eSheath 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 Mar 9, 2020 as substantially equivalent to K152225 (Edwards Lifesciences, 2015) and 1 other predicate after a 35-day review. Its family tree reaches back 8 generations to 1993. 2 of the 18 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it.
- Decided
- Mar 9, 2020
- Review
- 35 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K924607 (1993). 15 ancestors in all, the oldest K902469 (1990). 2 later devices descend from it, 1 citing it directly. 2 of the 18 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK924607 Arrow Fischell Kink Resist Percut Sheath Intro SetArrow Intl., Inc. · 1993 · Recalled
- 7 generations backK012812 Carotid Guiding SheathTerumo Medical Corp. · 2001 · Recalled
- 6 generations backK051601 Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2005
- 5 generations backK080415 Device Modification to Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2008
- 4 generations backK091329 Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2009 · Recalled
- 3 generations backK142829 Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor…Cook Incorporated · 2015 · Recalled (Class I)
- 2 generations backK152225 Edwards eSheath Introducer SetEdwards Lifesciences · 2015
- 1 generation backK162184 Edwards eSheath Introducer SetEdward Lifesciences · 2016
- This deviceK200258 Edwards eSheath Introducer SetEdwards Lifesciences · 2020
- Descendant · cites it directly · 1 of its ownK244046 Edwards eSheath Optima introducer setEdwards Lifesciences · 2025
- Descendant · 2 generations on · 0 of its ownK252364 Edwards eSheath Optima introducer setEdwards Lifesciences · 2025
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K924607 | Arrow Fischell Kink Resist Percut Sheath Intro Set | Arrow Intl., Inc. | 1993 | 3 |
| −7 | K012812 | Carotid Guiding Sheath | Terumo Medical Corp. | 2001 | 1 |
| −6 | K051601 | Pinnacle Destination Peripheral Guiding Sheath | Terumo Medical Corp. | 2005 | — |
| −5 | K080415 | Device Modification to Pinnacle Destination Peripheral Guiding Sheath | Terumo Medical Corp. | 2008 | — |
| −4 | K091329 | Pinnacle Destination Peripheral Guiding Sheath | Terumo Medical Corp. | 2009 | 1 |
| −3 | K142829 | Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo… | Cook Incorporated | 2015 | Class I |
| −2 | K152225 | Edwards eSheath Introducer Set | Edwards Lifesciences | 2015 | — |
| −1 | K162184 | Edwards eSheath Introducer Set | Edward Lifesciences | 2016 | — |
| 0 (this device) | K200258 | Edwards eSheath Introducer Set | Edwards Lifesciences | 2020 | — |
| +1 | K244046 | Edwards eSheath Optima introducer set | Edwards Lifesciences | 2025 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 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.
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? (2)
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 |
|---|---|---|---|
| * | K152225 | Edwards eSheath Introducer SetSummary page 4…troducer Classification: Catheter Introducer 21 CFR 870.1340, Product Code DYB Predicate Edwards eSheath Introducer Sheath Set (K152225) Devices: Edwards eSheath Introducer Sheath Set (K162184) Device Description: The Edwards eSheath Introducer Set co… | 2015 |
| * | K162184 | Edwards eSheath Introducer SetSummary page 4…21 CFR 870.1340, Product Code DYB Predicate Edwards eSheath Introducer Sheath Set (K152225) Devices: Edwards eSheath Introducer Sheath Set (K162184) Device Description: The Edwards eSheath Introducer Set contains two dilators and a sheath with hydrophilic coating, and loader… | 2016 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K244046 | Edwards eSheath Optima introducer set | 2025 | 1 |
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 · 2 generations back · ◆ on the line of descent in FIG. 121 Class I recalls
- K100819The Solopath Balloon Expandable Transfemoral IntroducerOnset Medical Corporation · 2010 · 2 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 27 years and passes through 5 companies; a new generation was cleared every 3.5 years on median.
- 6 of the 15 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K244046 (Edwards Lifesciences, 2025) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K152225.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Introducer Set is indicated for the introduction and removal of devices used with the Edwards SAPIEN 3 and the SAPIEN 3 Ultra transcatheter heart valves.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200258 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200258: Edwards eSheath Introducer Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200258
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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