510(k) · Cleared
ClearedSonoStik IV 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 Oct 1, 2015 as substantially equivalent to K111606 (Terumo Medical Corp., 2011) and 1 other predicate after a 58-day review. Its family tree reaches back 6 generations to 1995. 1 of the 20 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Oct 1, 2015
- Review
- 58 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K954234 (1995). 18 ancestors in all, the oldest K810675 (1981). 1 later device descends from it, 1 citing it directly. 1 of the 20 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK954234 Radifocus Introducer II KitTerumo Medical Corp. · 1995
- 5 generations backK033681 GlidesheathTerumo Corp. · 2003
- 4 generations backK062858 Modification to GlidesheathTerumo Medical Corp. · 2006
- 3 generations backK082644 GlidesheathTerumo Medical Corp. · 2008
- 2 generations backK102008 GlidesheathTerumo Medical Corp. · 2010 · Recalled
- 1 generation backK111606 Pinnacle Precision Access SystemTerumo Medical Corp. · 2011 · Recalled
- This deviceK152177 SonoStik IV Guide Wire IntroducerSonostik, LLC · 2015
- Descendant · cites it directly · 0 of its ownK243061 SonoStik Guide Wire IntroducerSonostik, LLC · 2024
Class I recalls in this family
- K810675 Arrow Radial Artery Catheterization Set5 generations back · 1981
Most influential descendants
Showing 1 of 1 · See all- K243061SonoStik Guide Wire IntroducerSonostik, LLC · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K954234 | Radifocus Introducer II Kit | Terumo Medical Corp. | 1995 | — |
| −5 | K033681 | Glidesheath | Terumo Corp. | 2003 | — |
| −4 | K062858 | Modification to Glidesheath | Terumo Medical Corp. | 2006 | — |
| −3 | K082644 | Glidesheath | Terumo Medical Corp. | 2008 | — |
| −2 | K102008 | Glidesheath | Terumo Medical Corp. | 2010 | 1 |
| −1 | K111606 | Pinnacle Precision Access System | Terumo Medical Corp. | 2011 | 1 |
| 0 (this device) | K152177 | SonoStik IV Guide Wire Introducer | Sonostik, LLC | 2015 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (2)
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 |
|---|---|---|---|
| * | K111606 | Pinnacle Precision Access SystemSummary page 4…repared: 09/15/15 Primary Predicate Device: Pinnacle Precision Access System, Terumo Medical Corp. (K111606) Additional Predicate Device: Endologix Guidewire, TechDevice Corporation (K110241) Indication for Use: The SonoStik Gui… | 2011 |
| * | K110241 | Endologix GuidewireSummary page 4…sion Access System, Terumo Medical Corp. (K111606) Additional Predicate Device: Endologix Guidewire, TechDevice Corporation (K110241) Indication for Use: The SonoStik Guide Wire Introducer is used to facilitate the introduction of a guide wire and catheter thro… | 2011 |
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 |
|---|---|---|---|
| K243061 | SonoStik Guide Wire Introducer | 2024 | 0 |
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 · 5 generations back · ◆ in the 1981 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 7 of the 18 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K243061 (Sonostik, LLC, 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K111606.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 as stated in the FDA summary.
https://510kreport.com/device/K152177 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152177: SonoStik IV 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/K152177
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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