510(k) · Cleared
ClearedThe Crosser S6 Catheter, the Crosser System Electronics, Model CRUS6, GEN200
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Flowcardia, Inc. · PDU Catheter For Crossing Total Occlusions
Cleared on Feb 17, 2010 as substantially equivalent to K080765 (Flowcardia, Inc., 2008) and 1 other predicate after a 211-day review. Its family tree reaches back 8 generations to 1989. 6 later devices descend from it.
- Decided
- Feb 17, 2010
- Review
- 211 days
- Class
- Class II
- Product code
- PDU
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K890505 (1989). 13 ancestors in all, the oldest K881787 (1988). 6 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 7 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
- 6 generations backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
- 5 generations backK011986 Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002
- 4 generations backK021323 Modification to Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002
- 3 generations backK032031 Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc. · 2004
- 2 generations backK062868 The Crosser Catheter, Model CR1100 and System Electronics, Model…Flowcardia, Inc. · 2007
- 1 generation backK072776 The Crosser SystemFlowcardia, Inc. · 2007 · Recalled
- This deviceK092175 The Crosser S6 Catheter, the Crosser System Electronics, Model…Flowcardia, Inc. · 2010
- Descendant · cites it directly · 2 of its ownK192211 SoundBite Console, SoundBite Active Wire 18Soundbite Medical Solution, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK112308 Crosser Recanalization SystemC.R. Bard, Inc. · 2011
- Descendant · 2 generations on · 1 of its ownK210839 SoundBite Crossing System - Peripheral (14P)Soundbite Medical Solutions, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK161208 CROSSER CTO Recanalization CatheterBard Peripheral Vacular, Inc. · 2016
- Descendant · 3 generations on · 0 of its ownK230159 SoundBite® Crossing System XS PeripheralSoundbite Medical Solutions, Inc. · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K192211SoundBite Console, SoundBite Active Wire 18Soundbite Medical Solution, Inc. · 2020 · cites it directly2descendants
- K112308Crosser Recanalization SystemC.R. Bard, Inc. · 2011 · cites it directly2descendants
- K210839SoundBite Crossing System - Peripheral (14P)Soundbite Medical Solutions, Inc. · 2021 · 2 generations on1descendant
- K161208CROSSER CTO Recanalization CatheterBard Peripheral Vacular, Inc. · 2016 · 2 generations on1descendant
- K230159SoundBite® Crossing System XS PeripheralSoundbite Medical Solutions, Inc. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K890505 | Usci Grey/Black Guide Wire | C.R. Bard, Inc. | 1989 | — |
| −7 | K961271 | Usci Commander Series Guide Wires | C.R. Bard, Inc. | 1996 | — |
| −6 | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat… | Guidant Corp. | 1999 | — |
| −5 | K011986 | Safe-Steer Guide Wire System | Intra Luminal Therapeutics, Inc. | 2002 | — |
| −4 | K021323 | Modification to Safe-Steer Guide Wire System | Intra Luminal Therapeutics, Inc. | 2002 | — |
| −3 | K032031 | Safe-Cross Radio Frequency Total Occlusion Crossing System | Intra Luminal Therapeutics, Inc. | 2004 | — |
| −2 | K062868 | The Crosser Catheter, Model CR1100 and System Electronics, Model FG1002-02 | Flowcardia, Inc. | 2007 | — |
| −1 | K072776 | The Crosser System | Flowcardia, Inc. | 2007 | 1 |
| 0 (this device) | K092175 | The Crosser S6 Catheter, the Crosser System Electronics, Model CRUS6, GEN200 | Flowcardia, Inc. | 2010 | — |
| +1 | K192211 | SoundBite Console, SoundBite Active Wire 18 | Soundbite Medical Solution, Inc. | 2020 | — |
| +1 | K112308 | Crosser Recanalization System | C.R. Bard, Inc. | 2011 | — |
| +2 | K210839 | SoundBite Crossing System - Peripheral (14P) | Soundbite Medical Solutions, Inc. | 2021 | — |
| +2 | K161208 | CROSSER CTO Recanalization Catheter | Bard Peripheral Vacular, Inc. | 2016 | — |
| +3 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | K080765 | Crosser LP SystemSummary page 1…me: Percutaneous Catheter Classification Name: Percutaneous Catheter, 74 DQY /21 CFR 870.1250 Predicate Devices The CROSSER LP System manufactured by FlowCardia, Inc. (K080765) The CROSSER System manufactured by FlowCardia, Inc. (K072776) Device Description The CROSSER S6 System consists of a re-usable… | 2008 |
| * | K072776 | The Crosser SystemSummary page 1…theter, 74 DQY /21 CFR 870.1250 Predicate Devices The CROSSER LP System manufactured by FlowCardia, Inc. (K080765) The CROSSER System manufactured by FlowCardia, Inc. (K072776) Device Description The CROSSER S6 System consists of a re-usable electronic Generator, Foot Switch, high-frequency Transducer,… | 2007 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 21 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K192211 (Soundbite Medical Solution, Inc., 2020) has gone furthest, with 2 descendants of its own.
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. 2010, 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 CROSSER S6 System is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions. The device is contraindicated for use in carotid arteries.
The CROSSER S6 Catheter is only intended for use with the CROSSER Electronics System. Refer to the CROSSER Electronics System Manual of Operations for proper use.
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/K092175 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092175: The Crosser S6 Catheter, the Crosser System Electronics, Model CRUS6, GEN200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092175
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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