510(k) · Cleared
ClearedPinnacle R/O or Redifocus Introducer R/O (Comprised of a Sheath & Dilator)
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 Jan 26, 1999 as substantially equivalent to K954234 (Terumo Medical Corp., 1995) after a 62-day review. Its family tree reaches back 1 generation to 1995. 23 later devices descend from it.
- Decided
- Jan 26, 1999
- Review
- 62 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954234 (1995). 23 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK954234 Radifocus Introducer II KitTerumo Medical Corp. · 1995
- This deviceK984260 Pinnacle R/O or Redifocus Introducer R/O (Comprised of a Sheath &…Terumo Medical Corp. · 1999
- Descendant · cites it directly · 16 of its ownK022170 Inner-Lock Locking Introducer SheathsRex Medical · 2003
- Descendant · 2 generations on · 15 of its ownK032569 Short Introducer SheathRex Medical · 2003
- Descendant · 2 generations on · 12 of its ownK033793 Cleaner II Rotational Thrombectomy SystemRex Medical · 2003
- Descendant · 2 generations on · 11 of its ownK040252 Cleaner Rotational Thrombectomy System KitRex Medical · 2004
- Descendant · 3 generations on · 10 of its ownK060904 Cleaner Rotational Thrombectomy SystemRex Medical, L.P. · 2006
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K022170Inner-Lock Locking Introducer SheathsRex Medical · 2003 · cites it directly16descendants
- K032569Short Introducer SheathRex Medical · 2003 · 2 generations on15descendants
- K033793Cleaner II Rotational Thrombectomy SystemRex Medical · 2003 · 2 generations on12descendants
- K040252Cleaner Rotational Thrombectomy System KitRex Medical · 2004 · 2 generations on11descendants
- K060904Cleaner Rotational Thrombectomy SystemRex Medical, L.P. · 2006 · 3 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954234 | Radifocus Introducer II Kit | Terumo Medical Corp. | 1995 | — |
| 0 (this device) | K984260 | Pinnacle R/O or Redifocus Introducer R/O (Comprised of a Sheath & Dilator) | Terumo Medical Corp. | 1999 | — |
| +1 | K022170 | Inner-Lock Locking Introducer Sheaths | Rex Medical | 2003 | — |
| +2 | K032569 | Short Introducer Sheath | Rex Medical | 2003 | — |
| +2 | K033793 | Cleaner II Rotational Thrombectomy System | Rex Medical | 2003 | — |
| +2 | K040252 | Cleaner Rotational Thrombectomy System Kit | Rex Medical | 2004 | — |
| +3 | K060904 | Cleaner Rotational Thrombectomy System | Rex Medical, L.P. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K954234 | Radifocus Introducer II KitSummary page 1…indwelling sheath while it remains in place within the vein or artery after removal of a catheter. Note: This is the same intended use as the RADIFOCUS® Introducer II, K954234. Device Description Pinnacle™ R/O is comprised of an introducer sheath and a dilator. The introducer sheath has a radiopaque ma… | 1995 |
What descends from it? (23)
See all 232 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?
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 PINNACLE R/O is used to facilitate placing a catheter through the skin into a vein or artery. The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery. The RADIFOCUS Obturator is also an accessory device which is used by placing it into the sheath to create an occlusion and further provide support to the wall of the indwelling sheath while it remains in place within the vein or artery after removal of a catheter.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984260 · printed Nov 5, 2026
Cite this page
510(k) Report. “K984260: Pinnacle R/O or Redifocus Introducer R/O (Comprised of a Sheath & Dilator).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K984260
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