510(k) · Cleared
Recalled · 2010Engage TR Introducer
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 Nov 4, 2009 as substantially equivalent to K091137 (St Jude Medical, 2009) and 3 other predicates after a 30-day review. Its family tree reaches back 5 generations to 1995. 1 of the 17 devices in its family, counting itself, has a Class I recall. It has been recalled 5 times.
- Decided
- Nov 4, 2009
- Review
- 30 days
- Class
- Class II
- Product code
- DYB
- Recalls
- 5
- Predicates
- 4
Its longest line of descent runs back 5 generations to K954234 (1995). 16 ancestors in all, the oldest K810675 (1981). No later device cites it as a predicate yet. 1 of the 17 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK954234 Radifocus Introducer II KitTerumo Medical Corp. · 1995
- 4 generations backK033681 GlidesheathTerumo Corp. · 2003
- 3 generations backK062858 Modification to GlidesheathTerumo Medical Corp. · 2006
- 2 generations backK082644 GlidesheathTerumo Medical Corp. · 2008
- 1 generation backK091137 Ultimum/Engage/Engage TRSt Jude Medical · 2009 · Recalled
- This deviceK093130 Engage TR IntroducerSt Jude Medical · 2009
Class I recalls in this family
- K810675 Arrow Radial Artery Catheterization Set4 generations back · 1981
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K954234 | Radifocus Introducer II Kit | Terumo Medical Corp. | 1995 | — |
| −4 | K033681 | Glidesheath | Terumo Corp. | 2003 | — |
| −3 | K062858 | Modification to Glidesheath | Terumo Medical Corp. | 2006 | — |
| −2 | K082644 | Glidesheath | Terumo Medical Corp. | 2008 | — |
| −1 | K091137 | Ultimum/Engage/Engage TR | St Jude Medical | 2009 | 5 |
| 0 (this device) | K093130 | Engage TR Introducer | St Jude Medical | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 1 |
| 1991 | 2 | 0 |
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 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? (4)
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 |
|---|---|---|---|
| * | K091137 | Ultimum/Engage/Engage TRSummary page 1…DYB 4.3 Device Description The modified Engage TR Introducer is essentially a modification of the previously cleared Engage/Engage TR/Ultimum introducer (K09 1137). The modified Engage TR Introducer is intended to provide easy access to the vascular system, while providing convenient tempo… | 2009 |
| * | K001346 | Ultimum Hemostasis Introducer, Model 4076XXSummary page 2…overed by this submission, is substantially equivalent to the St. Jude Medical Engage/Engage TR Introducer (K091137, April, 22, 2009), Ultimum Hemostasis Introducer (K001346, May 24, 2000), Strada Carotid Guiding Sheath, (K070166, April 06, 2007), and Fast Cath Hemostasis Introducer (K914090, October… | 2000 |
| * | K070166 | Strada Carotid Guiding SheathSummary page 2…o the St. Jude Medical Engage/Engage TR Introducer (K091137, April, 22, 2009), Ultimum Hemostasis Introducer (K001346, May 24, 2000), Strada Carotid Guiding Sheath, (K070166, April 06, 2007), and Fast Cath Hemostasis Introducer (K914090, October 28, 1991). St. Jude Medical… | 2007 |
| * | K914090 | Daig Fast Cath (TM) Introducer, ModificationSummary page 2…ril, 22, 2009), Ultimum Hemostasis Introducer (K001346, May 24, 2000), Strada Carotid Guiding Sheath, (K070166, April 06, 2007), and Fast Cath Hemostasis Introducer (K914090, October 28, 1991). St. Jude Medical 4-2 Engage TR Introducer… | 1991 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 4 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 1.9 years on median.
- 7 of the 16 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K091137.
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/K093130 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093130: Engage TR Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093130
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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