510(k) · Cleared
Recalled · 2010Ultimum/Engage/Engage TR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
St Jude Medical · DYB Introducer, Catheter
Cleared on Apr 22, 2009 as substantially equivalent to K001346 (St. Jude Medical, Inc., 2000) and 1 other predicate after a 2-day review. Its family tree reaches back 4 generations to 1995. 1 of the 13 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it. It has been recalled 5 times.
- Decided
- Apr 22, 2009
- Review
- 2 days
- Class
- Class II
- Product code
- DYB
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 4 generations to K954234 (1995). 10 ancestors in all, the oldest K810675 (1981). 2 later devices descend from it, 2 citing it directly. 1 of the 13 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK954234 Radifocus Introducer II KitTerumo Medical Corp. · 1995
- 3 generations backK033681 GlidesheathTerumo Corp. · 2003
- 2 generations backK062858 Modification to GlidesheathTerumo Medical Corp. · 2006
- 1 generation backK082644 GlidesheathTerumo Medical Corp. · 2008
- This deviceK091137 Ultimum/Engage/Engage TRSt Jude Medical · 2009
- Descendant · cites it directly · 0 of its ownK093130 Engage TR IntroducerSt Jude Medical · 2009 · Recalled
- Descendant · cites it directly · 0 of its ownK092575 Engage/Engage TRSt Jude Medical · 2009 · Recalled
Class I recalls in this family
- K810675 Arrow Radial Artery Catheterization Set3 generations back · 1981
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 |
|---|---|---|---|---|---|
| −4 | K954234 | Radifocus Introducer II Kit | Terumo Medical Corp. | 1995 | — |
| −3 | K033681 | Glidesheath | Terumo Corp. | 2003 | — |
| −2 | K062858 | Modification to Glidesheath | Terumo Medical Corp. | 2006 | — |
| −1 | K082644 | Glidesheath | Terumo Medical Corp. | 2008 | — |
| 0 (this device) | K091137 | Ultimum/Engage/Engage TR | St Jude Medical | 2009 | — |
| +1 | K093130 | Engage TR Introducer | St Jude Medical | 2009 | 5 |
| +1 | K092575 | Engage/Engage TR | St Jude Medical | 2009 | 5 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 1 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K001346 | Ultimum Hemostasis Introducer, Model 4076XXSummary page 2…onal device testing was required. 5.6. PREDICATE DEVICE The predicate devices are provided below: Product Name 510k # Ultimum Hemostasis K001346 (cleared 05/24/2000) Introducer (St. Jude Medical) GlideSheath (Terumo K082644 (cleared 09/18/2008) Corporation)… | 2000 |
| * | K082644 | GlidesheathSummary page 2…ded below: Product Name 510k # Ultimum Hemostasis K001346 (cleared 05/24/2000) Introducer (St. Jude Medical) GlideSheath (Terumo K082644 (cleared 09/18/2008) Corporation) 7 Ultimum/Engage Introduce… | 2008 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 28, 2010 | Not classified | Z-2179-2010 | Process design | Potential for a partial or complete separation of the Shaft (sheath) from the hub or a material break in the hub assembly just distal to the hemostasis seal. If either of these were to occur during use, it is likely that fluids would leak… |
| Jun 28, 2010 | Not classified | Z-2181-2010 | Process design | Potential for a partial or complete separation of the Shaft (sheath) from the hub or a material break in the hub assembly just distal to the hemostasis seal. If either of these were to occur during use, it is likely that fluids would leak… |
| Jun 28, 2010 | Not classified | Z-2180-2010 | Process design | Potential for a partial or complete separation of the Shaft (sheath) from the hub or a material break in the hub assembly just distal to the hemostasis seal. If either of these were to occur during use, it is likely that fluids would leak… |
| Jun 28, 2010 | Not classified | Z-2178-2010 | Process design | Potential for a partial or complete separation of the Shaft (sheath) from the hub or a material break in the hub assembly just distal to the hemostasis seal. If either of these were to occur during use, it is likely that fluids would leak… |
| Jun 28, 2010 | Not classified | Z-2182-2010 | Process design | Potential for a partial or complete separation of the Shaft (sheath) from the hub or a material break in the hub assembly just distal to the hemostasis seal. If either of these were to occur during use, it is likely that fluids would leak… |
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.
- K810675Arrow Radial Artery Catheterization SetArrow Intl., Inc. · 1981 · 3 generations back · ◆ in the 1981 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 2 of the 10 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K093130 (St Jude Medical, 2009) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K001346.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 introduction of angiographic catheters, closed end catheters, balloon catheters, and electrodes into a blood vessel (including but not limited to femoral, radial, and brachial access) where minimizing blood loss is essential.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091137 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091137: Ultimum/Engage/Engage TR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091137
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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