510(k) · Cleared
ClearedSonoStik Guide Wire Introducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sonostik, LLC · DYB Introducer, Catheter
Cleared on Nov 4, 2024 as substantially equivalent to K152177 (Sonostik, LLC, 2015) after a 38-day review. Its family tree reaches back 7 generations to 1995. 1 of the 20 devices in its family, counting itself, has a Class I recall.
- Decided
- Nov 4, 2024
- Review
- 38 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K954234 (1995). 19 ancestors in all, the oldest K810675 (1981). No later device cites it as a predicate yet. 1 of the 20 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK954234 Radifocus Introducer II KitTerumo Medical Corp. · 1995
- 6 generations backK033681 GlidesheathTerumo Corp. · 2003
- 5 generations backK062858 Modification to GlidesheathTerumo Medical Corp. · 2006
- 4 generations backK082644 GlidesheathTerumo Medical Corp. · 2008
- 3 generations backK102008 GlidesheathTerumo Medical Corp. · 2010 · Recalled
- 2 generations backK111606 Pinnacle Precision Access SystemTerumo Medical Corp. · 2011 · Recalled
- 1 generation backK152177 SonoStik IV Guide Wire IntroducerSonostik, LLC · 2015
- This deviceK243061 SonoStik Guide Wire IntroducerSonostik, LLC · 2024
Class I recalls in this family
- K810675 Arrow Radial Artery Catheterization Set6 generations back · 1981
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K954234 | Radifocus Introducer II Kit | Terumo Medical Corp. | 1995 | — |
| −6 | K033681 | Glidesheath | Terumo Corp. | 2003 | — |
| −5 | K062858 | Modification to Glidesheath | Terumo Medical Corp. | 2006 | — |
| −4 | K082644 | Glidesheath | Terumo Medical Corp. | 2008 | — |
| −3 | K102008 | Glidesheath | Terumo Medical Corp. | 2010 | 1 |
| −2 | K111606 | Pinnacle Precision Access System | Terumo Medical Corp. | 2011 | 1 |
| −1 | K152177 | SonoStik IV Guide Wire Introducer | Sonostik, LLC | 2015 | — |
| 0 (this device) | K243061 | SonoStik Guide Wire Introducer | Sonostik, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 1 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2011 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K152177 | SonoStik IV Guide Wire IntroducerSummary page 5…icate Device The proposed SonoStik Guide Wire Introducer is substantially equivalent to the SonoStik, LLC SonoStik Guide Wire Introducer (Product Code DYB) cleared under K152177. Device Description Summary The SonoStik Guide Wire Introducer is intended to facilitate the i… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K810675Arrow Radial Artery Catheterization SetArrow Intl., Inc. · 1981 · 6 generations back · ◆ in the 1981 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 7 of the 19 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 SonoStik Guide Wire Introducer is used to facilitate the introduction of a guide wire and catheter through the skin into a vein or artery of the peripheral vasculature. The SonoStik Guide Wire Introducer is not intended for use in the coronary arteries or neurovasculature.
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/K243061 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243061: SonoStik Guide Wire Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243061
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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