510(k) · Cleared
ClearedAcQGuide MAX Steerable Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acutus Medical, Inc. · DRA Catheter, Steerable
Cleared on May 14, 2021 as substantially equivalent to K162925 (Acutus Medical, Inc., 2017) after a 31-day review. Its family tree reaches back 5 generations to 2007. 1 later device descends from it.
- Decided
- May 14, 2021
- Review
- 31 days
- Class
- Class II
- Product code
- DRA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K070357 (2007). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK070357 Flexcath Steerable Sheath & DilatorCryocath Technologies, Inc. · 2007
- 4 generations backK081049 Flexcath Steerable Sheath & Dilator, Models 3FC10, 3FC12Cryocath Technologies, Inc. · 2008
- 3 generations backK102176 Flexcath Steerable Sheath (12 French), Flexcath Steerable Sheath (10…Medtronic Cryocath, LP · 2010 · Recalled
- 2 generations backK123591 Flexcath Advance Steerable Sheath (12 French)Medtronic Cryocath, LP · 2012
- 1 generation backK162925 AcQGuide Steerable SheathAcutus Medical, Inc. · 2017
- This deviceK211100 AcQGuide MAX Steerable SheathAcutus Medical, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK221044 AcQGuide® VUE Steerable SheathAcutus Medical, Inc. · 2022
Most influential descendants
Showing 1 of 1 · See all- K221044AcQGuide® VUE Steerable SheathAcutus Medical, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K070357 | Flexcath Steerable Sheath & Dilator | Cryocath Technologies, Inc. | 2007 | — |
| −4 | K081049 | Flexcath Steerable Sheath & Dilator, Models 3FC10, 3FC12 | Cryocath Technologies, Inc. | 2008 | — |
| −3 | K102176 | Flexcath Steerable Sheath (12 French), Flexcath Steerable Sheath (10 French)… | Medtronic Cryocath, LP | 2010 | 1 |
| −2 | K123591 | Flexcath Advance Steerable Sheath (12 French) | Medtronic Cryocath, LP | 2012 | — |
| −1 | K162925 | AcQGuide Steerable Sheath | Acutus Medical, Inc. | 2017 | — |
| 0 (this device) | K211100 | AcQGuide MAX Steerable Sheath | Acutus Medical, Inc. | 2021 | — |
| +1 | K221044 | AcQGuide® VUE Steerable Sheath | Acutus Medical, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 DRA? 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 DRA device
- #1 K262165 FARADRIVE™ Steerable Sheath (M004PF21M402)score 13.2 · 6 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 |
|---|---|---|---|
| * | K162925 | AcQGuide Steerable SheathSummary page 5…ort substantial equivalence of the AcQGuide® MAX Steerable Sheath, Model 900200 is the Acutus Medical, Inc. AcQGuide Steerable Sheath, Model 900002, cleared under 510(k) K162925. Predicate Device Manufacturer FDA 510(k) AcQGuide Steerable Sheath… | 2017 |
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 |
|---|---|---|---|
| K221044 | AcQGuide® VUE Steerable Sheath | 2022 | 0 |
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 14 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K221044 (Acutus Medical, Inc., 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DRA devicesDRA Catheter, Steerable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · DRA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRA
89in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRA
4so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRA
4,018in 2025
MAUDE reports naming product code DRA, 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 | 1 | — | 0 | 6 |
| 2008 | 1 | — | 1 | 23 |
| 2009 | 2 | — | 0 | 5 |
| 2010 | 3 | 29 | 0 | 2 |
| 2011 | 1 | — | 1 | 155 |
| 2012 | 4 | 70 | 0 | 89 |
| 2013 | 0 | — | 0 | 113 |
| 2014 | 1 | — | 0 | 212 |
| 2015 | 1 | — | 0 | 350 |
| 2016 | 4 | 123 | 0 | 481 |
| 2017 | 2 | — | 0 | 625 |
| 2018 | 1 | — | 0 | 633 |
| 2019 | 2 | — | 0 | 700 |
| 2020 | 1 | — | 0 | 703 |
| 2021 | 1 | — | 0 | 741 |
| 2022 | 2 | — | 0 | 652 |
| 2023 | 3 | 89 | 0 | 788 |
| 2024 | 0 | — | 0 | 1,962 |
| 2025 | 1 | — | 0 | 4,018 |
| 2026 | 1 | — | 4 | — |
What is it indicated for?
The AcQGuide MAX Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart.
The AcQGuide MAX deflection facilitates catheter positioning.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211100 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211100: AcQGuide MAX Steerable Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211100
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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