510(k) · Cleared
ClearedAmulet™ Steerable Delivery Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Medical · DQY Catheter, Percutaneous
Cleared on Apr 25, 2025 as substantially equivalent to K232690 (Abbott Medical, 2023) after a 70-day review. Its family tree reaches back 13 generations to 1989. 1 of the 52 devices in its family, counting itself, has a Class I recall.
- Decided
- Apr 25, 2025
- Review
- 70 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K893658 (1989). 51 ancestors in all, the oldest K770977 (1977). No later device cites it as a predicate yet. 1 of the 52 devices in this family, counting this one, has a Class I recall.
- Root · 13 generations backK893658 Percutaneous IntroducerMedamicus, Inc. · 1989
- 9 generations between
- 3 generations backK212026 Amplatzer Steerable Delivery SheathAbbott Medical · 2021 · Recalled
- 2 generations backK220340 Amplatzer Steerable Delivery SheathAbbott Medical · 2022 · Recalled (Class I)
- 1 generation backK232690 Amulet™ Steerable Delivery SheathAbbott Medical · 2023
- This deviceK250426 Amulet™ Steerable Delivery SheathAbbott Medical · 2025
Show all 13 generations
- Root · 13 generations backK893658 Percutaneous IntroducerMedamicus, Inc. · 1989
- 12 generations backK965167 Percutaneous Venous Introducer 10264Medamicus, Inc. · 1997
- 11 generations backK012130 Attain LDS 6216 Left-Heart Delivery SystemMedtronic Vascular · 2001
- 10 generations backK013517 10600 Deflectable Catheter System, Model 10600Medtronic Vascular · 2002
- 9 generations backK032312 Attain 6226DEF Deflectable Catheter Delivery SystemMedtronic Vascular · 2003
- 8 generations backK033989 Medtronic Selectsite Deflectable Catheter System, Models C304-S59…Medtronic Inc. Cardiac Rhythm Management · 2004
- 7 generations backK072313 Amplatzer Torqvue Delivery SystemAga Medical Corp. · 2007 · Recalled
- 6 generations backK083214 Amplatzer Torqvue 45DEGREEX45DEGREE Delivery Sheath, Models…Aga Medical Corp. · 2009
- 5 generations backK120120 Amplatzer Torqvue 45X45 Delivery Sheath Amplatzer Torqvue LA1…Aga Medical Corporation · 2012
- 4 generations backK163000 AMPLATZER TorqVue 45x45 Delivery SheathAga Medical COrporation (Wholly Owned by St. Jude Medical CO · 2016
- 3 generations backK212026 Amplatzer Steerable Delivery SheathAbbott Medical · 2021 · Recalled
- 2 generations backK220340 Amplatzer Steerable Delivery SheathAbbott Medical · 2022 · Recalled (Class I)
- 1 generation backK232690 Amulet™ Steerable Delivery SheathAbbott Medical · 2023
- This deviceK250426 Amulet™ Steerable Delivery SheathAbbott Medical · 2025
Class I recalls in this family
- K220340 Amplatzer Steerable Delivery Sheath2 generations back · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K893658 | Percutaneous Introducer | Medamicus, Inc. | 1989 | — |
| −12 | K965167 | Percutaneous Venous Introducer 10264 | Medamicus, Inc. | 1997 | — |
| −11 | K012130 | Attain LDS 6216 Left-Heart Delivery System | Medtronic Vascular | 2001 | — |
| −10 | K013517 | 10600 Deflectable Catheter System, Model 10600 | Medtronic Vascular | 2002 | — |
| −9 | K032312 | Attain 6226DEF Deflectable Catheter Delivery System | Medtronic Vascular | 2003 | — |
| −8 | K033989 | Medtronic Selectsite Deflectable Catheter System, Models C304-S59 and C304-L69 | Medtronic Inc. Cardiac Rhythm Management | 2004 | — |
| −7 | K072313 | Amplatzer Torqvue Delivery System | Aga Medical Corp. | 2007 | 1 |
| −6 | K083214 | Amplatzer Torqvue 45DEGREEX45DEGREE Delivery Sheath, Models 9-TV45X45-09F-100… | Aga Medical Corp. | 2009 | — |
| −5 | K120120 | Amplatzer Torqvue 45X45 Delivery Sheath Amplatzer Torqvue LA1 Delivery Sheath… | Aga Medical Corporation | 2012 | — |
| −4 | K163000 | AMPLATZER TorqVue 45x45 Delivery Sheath | Aga Medical COrporation (Wholly Owned by St. Jude Medical CO | 2016 | — |
| −3 | K212026 | Amplatzer Steerable Delivery Sheath | Abbott Medical | 2021 | 1 |
| −2 | K220340 | Amplatzer Steerable Delivery Sheath | Abbott Medical | 2022 | Class I |
| −1 | K232690 | Amulet™ Steerable Delivery Sheath | Abbott Medical | 2023 | — |
| 0 (this device) | K250426 | Amulet™ Steerable Delivery Sheath | Abbott Medical | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 3 | 0 |
| 1988 | 1 | 0 |
| 1990 | 5 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 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 DQY device
- #1 K234115 APRO 55 Catheterscore 17.5 · 6 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 |
|---|---|---|---|
| * | K232690 | Amulet™ Steerable Delivery SheathSummary page 5…870.1250) Device Class: II Product Code: DQY III. PREDICATE DEVICES Primary Predicate: Amulet™ Steerable Delivery Sheath (K232690, cleared 29 September 2023) IV. DEVICE DESCRIPTION The Amulet™ Steerable Delivery Sheath is designed to provide a pat… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 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.
- K220340Amplatzer Steerable Delivery SheathAbbott Medical · 2022 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 36 years and passes through 7 companies; a new generation was cleared every 1.6 years on median.
- 12 of the 51 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 2025
MAUDE reports naming product code DQY, 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 | 16 | 85 | 6 | 313 |
| 2008 | 31 | 66 | 12 | 496 |
| 2009 | 37 | 73 | 17 | 819 |
| 2010 | 22 | 74 | 32 | 1,293 |
| 2011 | 36 | 71 | 6 | 1,211 |
| 2012 | 30 | 87 | 2 | 1,191 |
| 2013 | 32 | 92 | 36 (1) | 1,352 |
| 2014 | 19 | 127 | 3 | 1,497 |
| 2015 | 27 | 118 | 3 | 2,337 |
| 2016 | 22 | 117 | 22 (7) | 2,252 |
| 2017 | 26 | 113 | 8 | 2,489 |
| 2018 | 25 | 106 | 2 | 2,855 |
| 2019 | 30 | 111 | 1 | 2,902 |
| 2020 | 20 | 120 | 2 | 2,889 |
| 2021 | 18 | 81 | 2 | 3,006 |
| 2022 | 18 | 74 | 0 | 2,643 |
| 2023 | 18 | 114 | 17 | 3,049 |
| 2024 | 16 | 87 | 1 | 3,190 |
| 2025 | 21 | 115 | 1 (1) | 3,056 |
| 2026 | 11 | 30 | 2 (1) | — |
What is it indicated for?
The Amulet™ Steerable Delivery Sheath is indicated to facilitate the delivery of the Amplatzer™ Amulet™ Left Atrial Appendage Occluder.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250426 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250426: Amulet™ Steerable Delivery Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250426
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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