510(k) · Cleared
ClearedR2P Destination Slender Guiding Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Medical Corporation · DYB Introducer, Catheter
Cleared on Jan 6, 2020 as substantially equivalent to K171491 (Terumo Medical Corporation, 2017) after a 55-day review. Its family tree reaches back 4 generations to 1993. 1 later device descends from it.
- Decided
- Jan 6, 2020
- Review
- 55 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K924607 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK924607 Arrow Fischell Kink Resist Percut Sheath Intro SetArrow Intl., Inc. · 1993 · Recalled
- 3 generations backK012812 Carotid Guiding SheathTerumo Medical Corp. · 2001 · Recalled
- 2 generations backK052185 Destination Carotid Guiding SheathTerumo Medical Corp. · 2005 · Recalled
- 1 generation backK171491 R2P Destination Slender Guiding SheathTerumo Medical Corporation · 2017
- This deviceK193125 R2P Destination Slender Guiding SheathTerumo Medical Corporation · 2020
- Descendant · cites it directly · 0 of its ownK261242 SimplGuidePendracare · 2026
Most influential descendants
Showing 1 of 1 · See all- K261242SimplGuidePendracare · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K924607 | Arrow Fischell Kink Resist Percut Sheath Intro Set | Arrow Intl., Inc. | 1993 | 3 |
| −3 | K012812 | Carotid Guiding Sheath | Terumo Medical Corp. | 2001 | 1 |
| −2 | K052185 | Destination Carotid Guiding Sheath | Terumo Medical Corp. | 2005 | 1 |
| −1 | K171491 | R2P Destination Slender Guiding Sheath | Terumo Medical Corporation | 2017 | — |
| 0 (this device) | K193125 | R2P Destination Slender Guiding Sheath | Terumo Medical Corporation | 2020 | — |
| +1 | K261242 | SimplGuide | Pendracare | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K171491 | R2P Destination Slender Guiding SheathSummary page 5…ification: Class II C. PREDICATE DEVICE (807.92(a)(3)) The legally marketed device(s) to which substantial equivalence is claimed is: • Predicate Device: K171491 – R2P™ Destination Slender™ Guiding Sheath, manufactured by Terumo Medical Corporation, USA D. REASON FOR 510(k) SUBMI… | 2017 |
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 |
|---|---|---|---|
| K261242 | SimplGuide | 2026 | 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?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 8.6 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K261242 (Pendracare, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K171491.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
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?
R2P™ Destination Slender™ Guiding Sheath is indicated for the introduction of interventional and diagnostic devices into the human vasculature through an access site, including but not limited to the radial artery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193125 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193125: R2P Destination Slender Guiding Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193125
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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