510(k) · Cleared
Recalled · Class I · 2026Abiomed 23 Fr Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abiomed, Inc. · DYB Introducer, Catheter
Cleared on Jun 15, 2020 as substantially equivalent to K122084 (Oscor, Inc., 2012) after a 49-day review. Its family tree reaches back 2 generations to 1994. 2 of the 3 devices in its family, counting itself, have a Class I recall. It has been recalled 13 times, including 13 Class I recalls.
- Decided
- Jun 15, 2020
- Review
- 49 days
- Class
- Class II
- Product code
- DYB
- Recalls
- 13 (13 Class I)
- Predicates
- 1
Its longest line of descent runs back 2 generations to K934901 (1994). No later device cites it as a predicate yet. 2 of the 3 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK934901 Tear-Away Sheath Introducer Set with Integral Hemostasis ValveThomas Medical Products, Inc. · 1994 · Recalled
- 1 generation backK122084 Introducer Set, Model Adelante-S SeriesOscor, Inc. · 2012 · Recalled (Class I)
- This deviceK201116 Abiomed 23 Fr SheathAbiomed, Inc. · 2020
Class I recalls in this family
- K122084 Introducer Set, Model Adelante-S Seriesdirect predicate · 2012
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K122084 | Introducer Set, Model Adelante-S SeriesSummary page 4…e Standard: (i.e. none established under section 514 of the F D & C Act.) C. Predicate Device: Oscor Adelante-S Introducer Series, K122084 D. Device Description: The Abiomed 23 Fr Sheath is packaged as a sterile kit, which includes an introducer sheath (consisting o… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 11, 2026 | Class I | Z-2685-2026 | Under Investigation by firm | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers… |
| Jun 11, 2026 | Class I | Z-2689-2026 | Under Investigation by firm | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers… |
| Jun 11, 2026 | Class I | Z-2688-2026 | Under Investigation by firm | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers… |
| Jun 11, 2026 | Class I | Z-2681-2026 | Under Investigation by firm | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers… |
| Jun 11, 2026 | Class I | Z-2690-2026 | Under Investigation by firm | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers… |
| Jun 11, 2026 | Class I | Z-2682-2026 | Under Investigation by firm | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers… |
| Jun 11, 2026 | Class I | Z-2691-2026 | Under Investigation by firm | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers… |
| Jun 11, 2026 | Class I | Z-2687-2026 | Under Investigation by firm | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers… |
| Jun 11, 2026 | Class I | Z-2684-2026 | Under Investigation by firm | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers… |
| Jun 11, 2026 | Class I | Z-2693-2026 | Under Investigation by firm | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers… |
| Jun 11, 2026 | Class I | Z-2683-2026 | Under Investigation by firm | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers… |
| Jun 11, 2026 | Class I | Z-2686-2026 | Under Investigation by firm | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers… |
| Jun 11, 2026 | Class I | Z-2692-2026 | Under Investigation by firm | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers… |
The 5 latest of 13 recalls; the web page lists all.
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.
- K122084Introducer Set, Model Adelante-S SeriesOscor, Inc. · 2012 · Direct predicate · ◆ on the line of descent in FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 18.6 years on median.
- 2 of the 2 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K122084.
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 Abiomed 23 Fr Sheath is intended for introduction of pacing leads or catheters.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201116 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201116: Abiomed 23 Fr Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201116
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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