510(k) · Cleared
Recalled · Class I · 2026Abiomed 14Fr Low Profile Introducer Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abiomed, Inc. · DYB Introducer, Catheter
Cleared on Aug 6, 2024 as substantially equivalent to K222113 (Abiomed, Inc., 2022) after a 54-day review. Its family tree reaches back 6 generations to 2003. 1 of the 9 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled 4 times, including 4 Class I recalls.
- Decided
- Aug 6, 2024
- Review
- 54 days
- Class
- Class II
- Product code
- DYB
- Recalls
- 4 (4 Class I)
- Predicates
- 1
Its longest line of descent runs back 6 generations to K032073 (2003). 7 ancestors in all, the oldest K013282 (2001). 1 later device descends from it, 1 citing it directly. 1 of the 9 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK032073 Gore Introducer Sheath with Silicone Pinch ValveW. L. Gore & Associates, Inc. · 2003
- 5 generations backK082356 Gore Introducer Sheath with Silicone Pinch ValveW. L. Gore & Associates, Inc. · 2008
- 4 generations backK093791 Gore Dryseal SheathW. L. Gore & Associates, Inc. · 2010
- 3 generations backK121234 Gore (R) Dryseal Sheath with Hydrophilic CoatingW. L. Gore & Associates, Inc. · 2012
- 2 generations backK160254 GORE DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc. · 2016 · Recalled
- 1 generation backK222113 Abiomed 14Fr Low Profile Introducer SetAbiomed, Inc. · 2022 · Recalled
- This deviceK241708 Abiomed 14Fr Low Profile Introducer KitAbiomed, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK252766 14Fr Low Profile Introducer KitAbiomed, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K25276614Fr Low Profile Introducer KitAbiomed, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K032073 | Gore Introducer Sheath with Silicone Pinch Valve | W. L. Gore & Associates, Inc. | 2003 | — |
| −5 | K082356 | Gore Introducer Sheath with Silicone Pinch Valve | W. L. Gore & Associates, Inc. | 2008 | — |
| −4 | K093791 | Gore Dryseal Sheath | W. L. Gore & Associates, Inc. | 2010 | — |
| −3 | K121234 | Gore (R) Dryseal Sheath with Hydrophilic Coating | W. L. Gore & Associates, Inc. | 2012 | — |
| −2 | K160254 | GORE DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | 2016 | 1 |
| −1 | K222113 | Abiomed 14Fr Low Profile Introducer Set | Abiomed, Inc. | 2022 | 1 |
| 0 (this device) | K241708 | Abiomed 14Fr Low Profile Introducer Kit | Abiomed, Inc. | 2024 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K222113 | Abiomed 14Fr Low Profile Introducer SetSummary page 4…escription: Catheter Introducer C. Predicate Device: The primary predicate device was the Abiomed 14Fr Low Profile Introducer Set, which is cleared under K222113. D. Device Description: The Abiomed 14Fr Low Profile Introducer Kit (Gen 2) is a sterile, single-use, prescription device. The 14… | 2022 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252766 | 14Fr Low Profile Introducer Kit | 2025 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 22, 2026 | Class I | Z-2599-2026 | Under Investigation by firm | Potential for thrombus formation during prolonged use of the introducer. |
| May 22, 2026 | Class I | Z-2600-2026 | Under Investigation by firm | Potential for thrombus formation during prolonged use of the introducer. |
| May 22, 2026 | Class I | Z-2601-2026 | Under Investigation by firm | Potential for thrombus formation during prolonged use of the introducer. |
| May 22, 2026 | Class I | Z-2602-2026 | Under Investigation by firm | Potential for thrombus formation during prolonged use of the introducer. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K252766 (Abiomed, Inc., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 14Fr Low Profile Introducer Kit 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 as stated in the FDA summary.
https://510kreport.com/device/K241708 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241708: Abiomed 14Fr Low Profile Introducer Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241708
Report an extraction error
Are you the manufacturer?
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