510(k) · Cleared
ClearedSoundBite® Crossing System XS Peripheral
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Soundbite Medical Solutions, Inc. · PDU Catheter For Crossing Total Occlusions
Cleared on Aug 28, 2023 as substantially equivalent to K210839 (Soundbite Medical Solutions, Inc., 2021) after a 221-day review. Its family tree reaches back 11 generations to 1989.
- Decided
- Aug 28, 2023
- Review
- 221 days
- Class
- Class II
- Product code
- PDU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K890505 (1989). 16 ancestors in all, the oldest K881787 (1988). No later device cites it as a predicate yet.
- Root · 11 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 7 generations between
- 3 generations backK092175 The Crosser S6 Catheter, the Crosser System Electronics, Model…Flowcardia, Inc. · 2010
- 2 generations backK192211 SoundBite Console, SoundBite Active Wire 18Soundbite Medical Solution, Inc. · 2020
- 1 generation backK210839 SoundBite Crossing System - Peripheral (14P)Soundbite Medical Solutions, Inc. · 2021
- This deviceK230159 SoundBite® Crossing System XS PeripheralSoundbite Medical Solutions, Inc. · 2023
Show all 11 generations
- Root · 11 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 10 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
- 9 generations backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
- 8 generations backK011986 Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002
- 7 generations backK021323 Modification to Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002
- 6 generations backK032031 Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc. · 2004
- 5 generations backK062868 The Crosser Catheter, Model CR1100 and System Electronics, Model…Flowcardia, Inc. · 2007
- 4 generations backK072776 The Crosser SystemFlowcardia, Inc. · 2007 · Recalled
- 3 generations backK092175 The Crosser S6 Catheter, the Crosser System Electronics, Model…Flowcardia, Inc. · 2010
- 2 generations backK192211 SoundBite Console, SoundBite Active Wire 18Soundbite Medical Solution, Inc. · 2020
- 1 generation backK210839 SoundBite Crossing System - Peripheral (14P)Soundbite Medical Solutions, Inc. · 2021
- This deviceK230159 SoundBite® Crossing System XS PeripheralSoundbite Medical Solutions, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K890505 | Usci Grey/Black Guide Wire | C.R. Bard, Inc. | 1989 | — |
| −10 | K961271 | Usci Commander Series Guide Wires | C.R. Bard, Inc. | 1996 | — |
| −9 | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat… | Guidant Corp. | 1999 | — |
| −8 | K011986 | Safe-Steer Guide Wire System | Intra Luminal Therapeutics, Inc. | 2002 | — |
| −7 | K021323 | Modification to Safe-Steer Guide Wire System | Intra Luminal Therapeutics, Inc. | 2002 | — |
| −6 | K032031 | Safe-Cross Radio Frequency Total Occlusion Crossing System | Intra Luminal Therapeutics, Inc. | 2004 | — |
| −5 | K062868 | The Crosser Catheter, Model CR1100 and System Electronics, Model FG1002-02 | Flowcardia, Inc. | 2007 | — |
| −4 | K072776 | The Crosser System | Flowcardia, Inc. | 2007 | 1 |
| −3 | K092175 | The Crosser S6 Catheter, the Crosser System Electronics, Model CRUS6, GEN200 | Flowcardia, Inc. | 2010 | — |
| −2 | K192211 | SoundBite Console, SoundBite Active Wire 18 | Soundbite Medical Solution, Inc. | 2020 | — |
| −1 | K210839 | SoundBite Crossing System - Peripheral (14P) | Soundbite Medical Solutions, Inc. | 2021 | — |
| 0 (this device) | K230159 | SoundBite® Crossing System XS Peripheral | Soundbite Medical Solutions, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 2 | 0 |
| 1998 | 2 | 0 |
| 2008 | 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 PDU? 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 PDU device
- #1 K262013 Kiba CTO Crossing Catheterscore 15.2 · 12 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 |
|---|---|---|---|
| * | K210839 | SoundBite Crossing System - Peripheral (14P)Summary page 4…Email: [email protected] Predicate Device: SoundBite® Crossing System – Peripheral (14P) [K210839] Reference Device: SoundBite® Crossing System – Peripheral [K192211] Device Description: The SoundBit… | 2021 |
| † | K192211 | SoundBite Console, SoundBite Active Wire 18 | 2020 |
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 34 years and passes through 6 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 16 ancestors has a recall of any class.
How does its category compare?
All PDU devicesPDU Catheter For Crossing Total Occlusions: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · PDU
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PDU
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PDU
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PDU
179in 2025
MAUDE reports naming product code PDU, 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 | 4 | 66 | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 3 | 49 | 0 | 0 |
| 2011 | 3 | 91 | 0 | 0 |
| 2012 | 6 | 68 | 0 | 0 |
| 2013 | 1 | — | 0 | 3 |
| 2014 | 3 | 97 | 0 | 10 |
| 2015 | 2 | — | 0 | 12 |
| 2016 | 2 | — | 0 | 26 |
| 2017 | 1 | — | 0 | 211 |
| 2018 | 0 | — | 0 | 97 |
| 2019 | 1 | — | 0 | 83 |
| 2020 | 2 | — | 2 | 129 |
| 2021 | 3 | 144 | 0 | 189 |
| 2022 | 4 | 139 | 0 | 156 |
| 2023 | 3 | 221 | 1 | 71 |
| 2024 | 1 | — | 0 | 92 |
| 2025 | 3 | 59 | 0 | 179 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The SoundBite® Crossing System XS Peripheral is indicated to facilitate the intraluminal placement of conventional guidewires or treatment devices beyond peripheral artery chronic total occlusions.
The SoundBite® Crossing System XS Peripheral is not intended for use in the carotid arteries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230159 · printed Nov 5, 2026
Cite this page
510(k) Report. “K230159: SoundBite® Crossing System XS Peripheral.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K230159
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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