510(k) · Cleared
ClearedPinnacle R/O II or Radifocus Introducer II
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 21, 2000 after an 18-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Nov 21, 2000
- Review
- 18 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK003424 Pinnacle R/O II or Radifocus Introducer IITerumo Medical Corp. · 2000
- Descendant · cites it directly · 3 of its ownK082847 Pinnacle Roii Introducer SheathTerumo Medical Corp. · 2008
- Descendant · 2 generations on · 2 of its ownK132592 Flexor Radial Hydrophilic Introducer Access SetCook, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 1 of its ownK152044 Flexor Radial Hydrophilic Introducer Access SetCook Incorporated · 2015
- Descendant · 4 generations on · 0 of its ownK171609 Check-Flo Performer Introducer Micropuncture Radial Artery Access SetCook Incorporated · 2018
- Descendant · cites it directly · 0 of its ownK062446 Modification to Pinnacle Roii Hiflow Introducer SheathTerumo Medical Corp. · 2006
Most influential descendants
Showing 5 of 5 · See all- K082847Pinnacle Roii Introducer SheathTerumo Medical Corp. · 2008 · cites it directly3descendants
- K132592Flexor Radial Hydrophilic Introducer Access SetCook, Inc. · 2014 · 2 generations on2descendants
- K152044Flexor Radial Hydrophilic Introducer Access SetCook Incorporated · 2015 · 3 generations on1descendant
- K171609Check-Flo Performer Introducer Micropuncture Radial Artery Access SetCook Incorporated · 2018 · 4 generations on0descendants
- K062446Modification to Pinnacle Roii Hiflow Introducer SheathTerumo Medical Corp. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003424 | Pinnacle R/O II or Radifocus Introducer II | Terumo Medical Corp. | 2000 | — |
| +1 | K082847 | Pinnacle Roii Introducer Sheath | Terumo Medical Corp. | 2008 | — |
| +2 | K132592 | Flexor Radial Hydrophilic Introducer Access Set | Cook, Inc. | 2014 | 7 |
| +3 | K152044 | Flexor Radial Hydrophilic Introducer Access Set | Cook Incorporated | 2015 | — |
| +4 | K171609 | Check-Flo Performer Introducer Micropuncture Radial Artery Access Set | Cook Incorporated | 2018 | — |
| +1 | K062446 | Modification to Pinnacle Roii Hiflow Introducer Sheath | Terumo Medical Corp. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 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? (5)
2 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, K082847 (Terumo Medical Corp., 2008) 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.
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/K003424 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003424: Pinnacle R/O II or Radifocus Introducer II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003424
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026