510(k) · Cleared
ClearedR2P SlenGuide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ashitaka Factory of Terumo Corporation · DQY Catheter, Percutaneous
Cleared on Oct 14, 2016 as substantially equivalent to K972978 (Cordis Corp., 1997) after a 133-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Oct 14, 2016
- Review
- 133 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K972978 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK972978 Vista Brite Tip Guiding CathetersCordis Corp. · 1997 · Recalled
- This deviceK161546 R2P SlenGuideAshitaka Factory of Terumo Corporation · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972978 | Vista Brite Tip Guiding Catheters | Cordis Corp. | 1997 | 1 |
| 0 (this device) | K161546 | R2P SlenGuide | Ashitaka Factory of Terumo Corporation | 2016 | — |
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 DQY? 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 DQY device
- #1 K234115 APRO 55 Catheterscore 17.5 · 6 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 |
|---|---|---|---|
| * | K972978 | Vista Brite Tip Guiding CathetersSummary page 5…ication: Class II C. PREDICATE DEVICES (807.92(a)(3)) The legally marketed device(s) to which substantial equivalence is claimed are: Predicate Device: K972978 – Vista Brite Tip Guiding Catheters, manufactured by Cordis Corporation. Reference Device 1: K142819 – Shuttle-SL F… | 1997 |
| † | K142819 | Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer Set | 2015 |
| † | K090040 | Radifocus Glidecath (or Radifocus Glidecath XP) | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 a recall.
- 2 other devices also cite its predicate K972978.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 2025
MAUDE reports naming product code DQY, 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 | 16 | 85 | 6 | 313 |
| 2008 | 31 | 66 | 12 | 496 |
| 2009 | 37 | 73 | 17 | 819 |
| 2010 | 22 | 74 | 32 | 1,293 |
| 2011 | 36 | 71 | 6 | 1,211 |
| 2012 | 30 | 87 | 2 | 1,191 |
| 2013 | 32 | 92 | 36 (1) | 1,352 |
| 2014 | 19 | 127 | 3 | 1,497 |
| 2015 | 27 | 118 | 3 | 2,337 |
| 2016 | 22 | 117 | 22 (7) | 2,252 |
| 2017 | 26 | 113 | 8 | 2,489 |
| 2018 | 25 | 106 | 2 | 2,855 |
| 2019 | 30 | 111 | 1 | 2,902 |
| 2020 | 20 | 120 | 2 | 2,889 |
| 2021 | 18 | 81 | 2 | 3,006 |
| 2022 | 18 | 74 | 0 | 2,643 |
| 2023 | 18 | 114 | 17 | 3,049 |
| 2024 | 16 | 87 | 1 | 3,190 |
| 2025 | 21 | 115 | 1 (1) | 3,056 |
| 2026 | 11 | 30 | 2 (1) | — |
What is it indicated for?
The R2P (radial to peripheral) SlenGuide is designed for the introduction of interventional and diagnostic devices into the peripheral vasculature of the lower extremities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161546 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161546: R2P SlenGuide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161546
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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