510(k) · Cleared
Recalled · Class II · 2023Abiomed 14Fr Low Profile Introducer Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abiomed, Inc. · DYB Introducer, Catheter
Cleared on Oct 13, 2022 as substantially equivalent to K160254 (W. L. Gore & Associates, Inc., 2016) after an 87-day review. Its family tree reaches back 5 generations to 2003. 1 of the 9 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it. It has been recalled once.
- Decided
- Oct 13, 2022
- Review
- 87 days
- Class
- Class II
- Product code
- DYB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K032073 (2003). 6 ancestors in all, the oldest K013282 (2001). 2 later devices descend from it, 1 citing it directly. 1 of the 9 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK032073 Gore Introducer Sheath with Silicone Pinch ValveW. L. Gore & Associates, Inc. · 2003
- 4 generations backK082356 Gore Introducer Sheath with Silicone Pinch ValveW. L. Gore & Associates, Inc. · 2008
- 3 generations backK093791 Gore Dryseal SheathW. L. Gore & Associates, Inc. · 2010
- 2 generations backK121234 Gore (R) Dryseal Sheath with Hydrophilic CoatingW. L. Gore & Associates, Inc. · 2012
- 1 generation backK160254 GORE DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc. · 2016 · Recalled
- This deviceK222113 Abiomed 14Fr Low Profile Introducer SetAbiomed, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK241708 Abiomed 14Fr Low Profile Introducer KitAbiomed, Inc. · 2024 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK252766 14Fr Low Profile Introducer KitAbiomed, Inc. · 2025
Class I recalls in this family
- K241708 Abiomed 14Fr Low Profile Introducer Kitcites it directly · 2024
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 |
|---|---|---|---|---|---|
| −5 | K032073 | Gore Introducer Sheath with Silicone Pinch Valve | W. L. Gore & Associates, Inc. | 2003 | — |
| −4 | K082356 | Gore Introducer Sheath with Silicone Pinch Valve | W. L. Gore & Associates, Inc. | 2008 | — |
| −3 | K093791 | Gore Dryseal Sheath | W. L. Gore & Associates, Inc. | 2010 | — |
| −2 | K121234 | Gore (R) Dryseal Sheath with Hydrophilic Coating | W. L. Gore & Associates, Inc. | 2012 | — |
| −1 | K160254 | GORE DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | 2016 | 1 |
| 0 (this device) | K222113 | Abiomed 14Fr Low Profile Introducer Set | Abiomed, Inc. | 2022 | — |
| +1 | K241708 | Abiomed 14Fr Low Profile Introducer Kit | Abiomed, Inc. | 2024 | Class I |
| +2 | K252766 | 14Fr Low Profile Introducer Kit | Abiomed, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 1 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K160254 | GORE DrySeal Flex Introducer SheathSummary page 4…tion Description: Catheter Introducer C. Predicate Device: The primary predicate device was the Gore DrySeal Flex Introducer Sheath, which is cleared under K160254. The reference device was the Teleflex 10 Fr Arrow Sheath, which is cleared under K780532. The predicate and reference devices h… | 2016 |
| † | K780532 | Percutaneous Sheath Introducer Kit | 1978 |
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 |
|---|---|---|---|
| K241708 | Abiomed 14Fr Low Profile Introducer Kit Class I | 2024 | 1 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 26, 2023 | Class II | Z-2128-2023 | Under Investigation by firm | There was one complaint that the sidearm of the device detached during explant of a pump. When the sidearms are subjected to heat, humidity and articulation, a silicone oil contaminant that was unintentionally introduced during… |
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.
- K241708Abiomed 14Fr Low Profile Introducer KitAbiomed, Inc. · 2024 · Cites it directly · ◆ in the 2024 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K241708 (Abiomed, Inc., 2024) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K160254.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 14 Fr Low Profile Introducer Set is intended to facilitate access to the vascular system for the introduction and removal of the Impella CP Catheter and ancillary devices
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/K222113 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222113: Abiomed 14Fr Low Profile 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/K222113
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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