510(k) · Cleared
ClearedSimplGuide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pendracare · DYB Introducer, Catheter
Cleared on Jun 25, 2026 as substantially equivalent to K193125 (Terumo Medical Corporation, 2020) after a 71-day review. Its family tree reaches back 5 generations to 1993.
- Decided
- Jun 25, 2026
- Review
- 71 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K924607 (1993). No later device cites it as a predicate yet.
- Root · 5 generations backK924607 Arrow Fischell Kink Resist Percut Sheath Intro SetArrow Intl., Inc. · 1993 · Recalled
- 4 generations backK012812 Carotid Guiding SheathTerumo Medical Corp. · 2001 · Recalled
- 3 generations backK052185 Destination Carotid Guiding SheathTerumo Medical Corp. · 2005 · Recalled
- 2 generations backK171491 R2P Destination Slender Guiding SheathTerumo Medical Corporation · 2017
- 1 generation backK193125 R2P Destination Slender Guiding SheathTerumo Medical Corporation · 2020
- This deviceK261242 SimplGuidePendracare · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K924607 | Arrow Fischell Kink Resist Percut Sheath Intro Set | Arrow Intl., Inc. | 1993 | 3 |
| −4 | K012812 | Carotid Guiding Sheath | Terumo Medical Corp. | 2001 | 1 |
| −3 | K052185 | Destination Carotid Guiding Sheath | Terumo Medical Corp. | 2005 | 1 |
| −2 | K171491 | R2P Destination Slender Guiding Sheath | Terumo Medical Corporation | 2017 | — |
| −1 | K193125 | R2P Destination Slender Guiding Sheath | Terumo Medical Corporation | 2020 | — |
| 0 (this device) | K261242 | SimplGuide | Pendracare | 2026 | — |
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 |
|---|---|---|---|
| * | K193125 | R2P Destination Slender Guiding SheathSummary page 5…C. Predicate Device information The legally marketed devices which the 510(k) used for claiming equivalence are • R2P Destination Slender Guiding Sheath (K193125) (Predicate device) • Convey 7F Guiding Catheters (K132197, July 11, 2013) (Reference device) • Primum Hydrophi… | 2020 |
| † | K132197 | Convey 7F Guiding Catheter, Convey 8F Guiding Catheter | 2013 |
| † | K250972 | Primum Hydrophilic Guiding Catheter | 2025 |
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?
- The line of descent spans 33 years and passes through 4 companies; a new generation was cleared every 6.5 years on median.
- 3 of the 5 ancestors have a recall of any class.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
The SimplGuide guiding sheath is indicated for the introduction of therapeutic and diagnostic devices into the peripheral and coronary vasculature through an access site.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261242 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261242: SimplGuide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261242
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026