510(k) · Cleared
ClearedAcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acutus Medical, Inc. · DYB Introducer, Catheter
Cleared on Jan 17, 2020 as substantially equivalent to K170373 (Rhythm Xience, Inc. (Rxi), 2017) and 1 other predicate after a 30-day review. Its family tree reaches back 4 generations to 1997. 3 later devices descend from it.
- Decided
- Jan 17, 2020
- Review
- 30 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K964518 (1997). 8 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK964518 Fast-Cath Transseptal Catheter IntroducerDaig Corp. · 1997 · Recalled
- 3 generations backK042623 Agilis Steerable Catheter Introducer, Model 408304St. Jude Medical, Daig Division, Inc. · 2005 · Recalled
- 2 generations backK061363 Agilis NXT Steerable IntroducerSt Jude Medical · 2006 · Recalled
- 1 generation backK170373 Flextra Steerable IntroducerRhythm Xience, Inc. (Rxi) · 2017 · Recalled
- This deviceK193509 AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QXAcutus Medical, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK210685 AcQCross Qx Integrated Transseptal Dilator/NeedleAcutus Medical, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK233691 FlexCath Cross Transseptal SolutionAcutus Medical, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK220047 AcQCross Qx Integrated Transseptal Dilator/NeedleAcutus Medical, Inc. · 2022
Most influential descendants
Showing 3 of 3 · See all- K210685AcQCross Qx Integrated Transseptal Dilator/NeedleAcutus Medical, Inc. · 2021 · cites it directly2descendants
- K233691FlexCath Cross Transseptal SolutionAcutus Medical, Inc. · 2023 · 2 generations on0descendants
- K220047AcQCross Qx Integrated Transseptal Dilator/NeedleAcutus Medical, Inc. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K964518 | Fast-Cath Transseptal Catheter Introducer | Daig Corp. | 1997 | 4 |
| −3 | K042623 | Agilis Steerable Catheter Introducer, Model 408304 | St. Jude Medical, Daig Division, Inc. | 2005 | 1 |
| −2 | K061363 | Agilis NXT Steerable Introducer | St Jude Medical | 2006 | 1 |
| −1 | K170373 | Flextra Steerable Introducer | Rhythm Xience, Inc. (Rxi) | 2017 | 4 |
| 0 (this device) | K193509 | AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX | Acutus Medical, Inc. | 2020 | — |
| +1 | K210685 | AcQCross Qx Integrated Transseptal Dilator/Needle | Acutus Medical, Inc. | 2021 | — |
| +2 | K233691 | FlexCath Cross Transseptal Solution | Acutus Medical, Inc. | 2023 | — |
| +2 | K220047 | AcQCross Qx Integrated Transseptal Dilator/Needle | Acutus Medical, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 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 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? (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 |
|---|---|---|---|
| * | K170373 | Flextra Steerable IntroducerSummary page 4…able 3: Predicate Devices Predicate Device Manufacturer FDA 510(k) Flextra Steerable Introducer Set Acutus Medical K170373 Guider Catheter Introducer Set Acutus Medical K171081 In the same manner as the current ECG adapter cable is… | 2017 |
| * | K171081 | Guider Catheter IntroducerSummary page 4…turer FDA 510(k) Flextra Steerable Introducer Set Acutus Medical K170373 Guider Catheter Introducer Set Acutus Medical K171081 In the same manner as the current ECG adapter cable is attached to the AcQCross Qx dilator/transseptal needle, a new electrosurgi… | 2017 |
| † | K073326 | NRG Transseptal Needle | 2008 |
| † | K192016 | Smoov O10 | 2020 |
| † | K171557 | AcQRef Introducer Sheath | 2018 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210685 | AcQCross Qx Integrated Transseptal Dilator/Needle | 2021 | 2 |
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 23 years and passes through 5 companies; a new generation was cleared every 7.7 years on median.
- 5 of the 8 ancestors have a recall of any class.
- Of its descendants, K210685 (Acutus Medical, Inc., 2021) has gone furthest, with 2 descendants of its own.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 AcQGuide® Catheter Introducer Sets are indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193509 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193509: AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193509
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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