510(k) · Cleared
Recalled · Class I · 2025WATCHMAN TruSteer Access System (M635TU90050)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · DQY Catheter, Percutaneous
Cleared on Feb 1, 2024 as substantially equivalent to K212228 (Boston Scientific Corporation, 2021) after a 30-day review. Its family tree reaches back 10 generations to 1989. 3 of the 43 devices in its family, counting itself, have a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- Feb 1, 2024
- Review
- 30 days
- Class
- Class II
- Product code
- DQY
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 10 generations to K893658 (1989). 42 ancestors in all, the oldest K770977 (1977). No later device cites it as a predicate yet. 3 of the 43 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK893658 Percutaneous IntroducerMedamicus, Inc. · 1989
- 6 generations between
- 3 generations backK083214 Amplatzer Torqvue 45DEGREEX45DEGREE Delivery Sheath, Models…Aga Medical Corp. · 2009
- 2 generations backK180864 WATCHMAN TruSeal Access SystemBoston Scientific · 2018 · Recalled (Class I)
- 1 generation backK212228 WATCHMAN FXD Curve Access SystemBoston Scientific Corporation · 2021 · Recalled (Class I)
- This deviceK240018 WATCHMAN TruSteer Access System (M635TU90050)Boston Scientific Corporation · 2024
Show all 10 generations
- Root · 10 generations backK893658 Percutaneous IntroducerMedamicus, Inc. · 1989
- 9 generations backK965167 Percutaneous Venous Introducer 10264Medamicus, Inc. · 1997
- 8 generations backK012130 Attain LDS 6216 Left-Heart Delivery SystemMedtronic Vascular · 2001
- 7 generations backK013517 10600 Deflectable Catheter System, Model 10600Medtronic Vascular · 2002
- 6 generations backK032312 Attain 6226DEF Deflectable Catheter Delivery SystemMedtronic Vascular · 2003
- 5 generations backK033989 Medtronic Selectsite Deflectable Catheter System, Models C304-S59…Medtronic Inc. Cardiac Rhythm Management · 2004
- 4 generations backK072313 Amplatzer Torqvue Delivery SystemAga Medical Corp. · 2007 · Recalled
- 3 generations backK083214 Amplatzer Torqvue 45DEGREEX45DEGREE Delivery Sheath, Models…Aga Medical Corp. · 2009
- 2 generations backK180864 WATCHMAN TruSeal Access SystemBoston Scientific · 2018 · Recalled (Class I)
- 1 generation backK212228 WATCHMAN FXD Curve Access SystemBoston Scientific Corporation · 2021 · Recalled (Class I)
- This deviceK240018 WATCHMAN TruSteer Access System (M635TU90050)Boston Scientific Corporation · 2024
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K893658 | Percutaneous Introducer | Medamicus, Inc. | 1989 | — |
| −9 | K965167 | Percutaneous Venous Introducer 10264 | Medamicus, Inc. | 1997 | — |
| −8 | K012130 | Attain LDS 6216 Left-Heart Delivery System | Medtronic Vascular | 2001 | — |
| −7 | K013517 | 10600 Deflectable Catheter System, Model 10600 | Medtronic Vascular | 2002 | — |
| −6 | K032312 | Attain 6226DEF Deflectable Catheter Delivery System | Medtronic Vascular | 2003 | — |
| −5 | K033989 | Medtronic Selectsite Deflectable Catheter System, Models C304-S59 and C304-L69 | Medtronic Inc. Cardiac Rhythm Management | 2004 | — |
| −4 | K072313 | Amplatzer Torqvue Delivery System | Aga Medical Corp. | 2007 | 1 |
| −3 | K083214 | Amplatzer Torqvue 45DEGREEX45DEGREE Delivery Sheath, Models 9-TV45X45-09F-100… | Aga Medical Corp. | 2009 | — |
| −2 | K180864 | WATCHMAN TruSeal Access System | Boston Scientific | 2018 | Class I |
| −1 | K212228 | WATCHMAN FXD Curve Access System | Boston Scientific Corporation | 2021 | Class I |
| 0 (this device) | K240018 | WATCHMAN TruSteer Access System (M635TU90050) | Boston Scientific Corporation | 2024 | — |
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 |
| 1999 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 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.
3 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 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 |
|---|---|---|---|
| * | K212228 | WATCHMAN FXD Curve Access SystemSummary page 5…atheter, Percutaneous Product Code DQY Classification Class II, 21 CFR Part 870.1250 Predicate Device WATCHMAN FXD Curve™ Access System, K212228, cleared 13 August 2021 Device Description The Boston Scientific WATCHMAN TruSteer™ Access… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 29, 2025 | Class I | Z-2436-2025 | Under Investigation by firm | Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures… |
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.
What does this lineage say?
- The line of descent spans 35 years and passes through 6 companies; a new generation was cleared every 3.1 years on median.
- 8 of the 42 ancestors have a recall of any class; 2 have 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. 2024, 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 WATCHMAN TruSteer Access System is intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240018 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240018: WATCHMAN TruSteer Access System (M635TU90050).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240018
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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