510(k) · Cleared
ClearedModification to Ultimum EV Hemostasis Introducer (22F)
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 Oct 31, 2002 as substantially equivalent to K003729 (St Jude Medical, 2001) after a 16-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.
- Decided
- Oct 31, 2002
- Review
- 16 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003729 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK003729 Ultimum EV Hemostasis Introducer (14F), Ultimum EV Hemostasis…St Jude Medical · 2001
- This deviceK023447 Modification to Ultimum EV Hemostasis Introducer (22F)St Jude Medical · 2002
- Descendant · cites it directly · 0 of its ownK140327 Ultimum EV Hemostasis IntroducerSt Jude Medical · 2014
Most influential descendants
Showing 1 of 1 · See all- K140327Ultimum EV Hemostasis IntroducerSt Jude Medical · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003729 | Ultimum EV Hemostasis Introducer (14F), Ultimum EV Hemostasis Introducer… | St Jude Medical | 2001 | — |
| 0 (this device) | K023447 | Modification to Ultimum EV Hemostasis Introducer (22F) | St Jude Medical | 2002 | — |
| +1 | K140327 | Ultimum EV Hemostasis Introducer | St Jude Medical | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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.
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 |
|---|---|---|---|
| * | K003729 | Ultimum EV Hemostasis Introducer (14F), Ultimum EV Hemostasis Introducer (16F), Ultimum…Summary page 1…emostasis Introducer, 22F, to be substantially equivalent to the predicate device, UltimumTMEV Hemostasis Introducers which received marketing clearance January 3,200 1 (K003729) Confirmatory testing included tensile testing, flexure testing, hemostasis seal testing and visibility testing comparing competi… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140327 | Ultimum EV Hemostasis Introducer | 2014 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K140327 (St Jude Medical, 2014) has gone furthest, with 0 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.
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 UltimumTMEV Hemostasis introducers are designed for the introduction of angiographic catheters, closed end catheters, balloon catheters and electrodes into a vessel where minimizing the blood loss is essential.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023447 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023447: Modification to Ultimum EV Hemostasis Introducer (22F).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023447
Report an extraction error
Are you the manufacturer?
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