510(k) · Cleared
ClearedRadifocus Introducer II Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Medical Corp. · DYB Introducer, Catheter
Cleared on Nov 27, 1995 after a 77-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 93 later devices descend from it.
- Decided
- Nov 27, 1995
- Review
- 77 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 0
93 later devices descend from it, 5 citing it directly.
- This deviceK954234 Radifocus Introducer II KitTerumo Medical Corp. · 1995
- Descendant · cites it directly · 43 of its ownK033681 GlidesheathTerumo Corp. · 2003
- Descendant · 2 generations on · 42 of its ownK062858 Modification to GlidesheathTerumo Medical Corp. · 2006
- Descendant · 3 generations on · 41 of its ownK082644 GlidesheathTerumo Medical Corp. · 2008
- Descendant · cites it directly · 30 of its ownK052557 Super Sheath Introducer SheathTogo Medikit Co., Ltd. · 2006 · Recalled
- Descendant · cites it directly · 23 of its ownK984260 Pinnacle R/O or Redifocus Introducer R/O (Comprised of a Sheath &…Terumo Medical Corp. · 1999
Showing 5 of 93 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 93 · See all- K033681GlidesheathTerumo Corp. · 2003 · cites it directly43descendants
- K062858Modification to GlidesheathTerumo Medical Corp. · 2006 · 2 generations on42descendants
- K082644GlidesheathTerumo Medical Corp. · 2008 · 3 generations on41descendants
- K052557Super Sheath Introducer SheathTogo Medikit Co., Ltd. · 2006 · cites it directly30descendants
- K984260Pinnacle R/O or Redifocus Introducer R/O (Comprised of a Sheath & Dilator)Terumo Medical Corp. · 1999 · cites it directly23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954234 | Radifocus Introducer II Kit | Terumo Medical Corp. | 1995 | — |
| +1 | K033681 | Glidesheath | Terumo Corp. | 2003 | — |
| +2 | K062858 | Modification to Glidesheath | Terumo Medical Corp. | 2006 | — |
| +3 | K082644 | Glidesheath | Terumo Medical Corp. | 2008 | — |
| +1 | K052557 | Super Sheath Introducer Sheath | Togo Medikit Co., Ltd. | 2006 | 1 |
| +1 | K984260 | Pinnacle R/O or Redifocus Introducer R/O (Comprised of a Sheath & Dilator) | Terumo Medical Corp. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 5 | 0 |
| 2011 | 5 | 0 |
| 2012 | 5 | 0 |
| 2013 | 4 | 0 |
| 2014 | 11 | 0 |
| 2015 | 7 | 0 |
| 2016 | 3 | 0 |
| 2017 | 6 | 0 |
| 2018 | 9 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (93)
See all 935 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K033681 (Terumo Corp., 2003) has gone furthest, with 43 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) | — |
https://510kreport.com/device/K954234 · printed Nov 5, 2026
Cite this page
510(k) Report. “K954234: Radifocus Introducer II Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K954234
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026