510(k) · Cleared
ClearedAuST Steerable Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CenterPoint Systems, LLC · DYB Introducer, Catheter
Cleared on Oct 4, 2024 as substantially equivalent to K240829 (CenterPoint Systems, LLC, 2024) after a 78-day review. Its family tree reaches back 9 generations to 1989. 4 later devices descend from it.
- Decided
- Oct 4, 2024
- Review
- 78 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K893658 (1989). 66 ancestors in all, the oldest K770977 (1977). 4 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK893658 Percutaneous IntroducerMedamicus, Inc. · 1989
- 5 generations between
- 3 generations backK122960 Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc. · 2012
- 2 generations backK151951 Destino ReachOscor, Inc. · 2015
- 1 generation backK240829 AuST Steerable SheathCenterPoint Systems, LLC · 2024
- This deviceK242106 AuST Steerable SheathCenterPoint Systems, LLC · 2024
- Descendant · cites it directly · 3 of its ownK251051 AuST Steerable SheathCenterPoint Systems, LLC · 2025
- Descendant · 2 generations on · 1 of its ownK260942 AuST Steerable SheathCenterPoint Systems, LLC · 2026
- Descendant · 3 generations on · 0 of its ownK261492 FieldFlex Steerable SheathCenterPoint Systems, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK260163 AuST CSP IntroducerCenterPoint Systems, LLC · 2026
Show all 9 generations
- Root · 9 generations backK893658 Percutaneous IntroducerMedamicus, Inc. · 1989
- 8 generations backK965167 Percutaneous Venous Introducer 10264Medamicus, Inc. · 1997
- 7 generations backK012130 Attain LDS 6216 Left-Heart Delivery SystemMedtronic Vascular · 2001
- 6 generations backK013517 10600 Deflectable Catheter System, Model 10600Medtronic Vascular · 2002
- 5 generations backK043489 Enpath Deflectable CatheterEnpath Medical Incorporated · 2005 · Recalled
- 4 generations backK061119 Enpath Medical Steerable SheathEnpath Medical, Inc. · 2006
- 3 generations backK122960 Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc. · 2012
- 2 generations backK151951 Destino ReachOscor, Inc. · 2015
- 1 generation backK240829 AuST Steerable SheathCenterPoint Systems, LLC · 2024
- This deviceK242106 AuST Steerable SheathCenterPoint Systems, LLC · 2024
Most influential descendants
Showing 4 of 4 · See all- K251051AuST Steerable SheathCenterPoint Systems, LLC · 2025 · cites it directly3descendants
- K260942AuST Steerable SheathCenterPoint Systems, LLC · 2026 · 2 generations on1descendant
- K261492FieldFlex Steerable SheathCenterPoint Systems, LLC · 2026 · 3 generations on0descendants
- K260163AuST CSP IntroducerCenterPoint Systems, LLC · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K893658 | Percutaneous Introducer | Medamicus, Inc. | 1989 | — |
| −8 | K965167 | Percutaneous Venous Introducer 10264 | Medamicus, Inc. | 1997 | — |
| −7 | K012130 | Attain LDS 6216 Left-Heart Delivery System | Medtronic Vascular | 2001 | — |
| −6 | K013517 | 10600 Deflectable Catheter System, Model 10600 | Medtronic Vascular | 2002 | — |
| −5 | K043489 | Enpath Deflectable Catheter | Enpath Medical Incorporated | 2005 | 2 |
| −4 | K061119 | Enpath Medical Steerable Sheath | Enpath Medical, Inc. | 2006 | — |
| −3 | K122960 | Steerable Guiding Sheath, Model Adelante Destino | Oscor, Inc. | 2012 | — |
| −2 | K151951 | Destino Reach | Oscor, Inc. | 2015 | — |
| −1 | K240829 | AuST Steerable Sheath | CenterPoint Systems, LLC | 2024 | — |
| 0 (this device) | K242106 | AuST Steerable Sheath | CenterPoint Systems, LLC | 2024 | — |
| +1 | K251051 | AuST Steerable Sheath | CenterPoint Systems, LLC | 2025 | — |
| +2 | K260942 | AuST Steerable Sheath | CenterPoint Systems, LLC | 2026 | — |
| +3 | K261492 | FieldFlex Steerable Sheath | CenterPoint Systems, LLC | 2026 | — |
| +2 | K260163 | AuST CSP Introducer | CenterPoint Systems, LLC | 2026 | — |
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 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 3 | 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.
Planning a device in DYB? 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 |
|---|---|---|---|
| * | K240829 | AuST Steerable SheathSummary page 5…latory Class: Class II per 21 CFR 870.1340 Product Code: DYB 1.3 Predicate Device Predicate Name and 510(k) Number: AuST Steerable Sheath, K240829 This predicate has not been subject to a design-related recall. 1.4 Device Description The modified AuST Steerable Sheath is… | 2024 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251051 | AuST Steerable Sheath | 2025 | 3 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
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.
- 20 of the 66 ancestors have a recall of any class.
- Of its descendants, K251051 (CenterPoint Systems, LLC, 2025) has gone furthest, with 3 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 AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal and other peripheral placements. Do not use this device for neural placements.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242106 · printed Nov 5, 2026
Cite this page
510(k) Report. “K242106: AuST Steerable Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K242106
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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