510(k) · Cleared
ClearedAptus Heli-FX Guide - 22CM Deflectable Length; Aptus Heli-FX Guide - 28CM Deflectable Length; Aptus Heli-FX Applier with
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aptus Endosystems, Inc. · OTD Endovascular Suturing System
Cleared on Feb 6, 2014 as substantially equivalent to DEN100026 (Aptus Endosystems, Inc., 2011) and 2 other predicates after a 30-day review. Its family tree reaches back 3 generations to 2011. 3 later devices descend from it.
- Decided
- Feb 6, 2014
- Review
- 30 days
- Class
- Class II
- Product code
- OTD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to DEN100026 (2011). 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backDEN100026 Aptus Steerable Endoguide with Obturator, Aptus Endostaple Applier…Aptus Endosystems, Inc. · 2011
- 2 generations backK121168 Aptus 18FR Helifx Guide-22 Deflectable LengthAptus Endosystems, Inc. · 2012
- 1 generation backK130677 Aptus Heli-FX Aortic Securement SystemAptus Endosystems, Inc. · 2013
- This deviceK140036 Aptus Heli-FX Guide - 22CM Deflectable Length; Aptus Heli-FX Guide -…Aptus Endosystems, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK141041 Aptus Heli-FX Ancillary Endoanchor CassetteAptus Endosystems · 2014
- Descendant · cites it directly · 1 of its ownK171427 Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor CassetteMedtronic Vascular, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 0 of its ownK182957 Heli-FX EndoAnchor SystemMedtronic Vascular, Inc. · 2018
Most influential descendants
Showing 3 of 3 · See all- K141041Aptus Heli-FX Ancillary Endoanchor CassetteAptus Endosystems · 2014 · cites it directly2descendants
- K171427Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor CassetteMedtronic Vascular, Inc. · 2017 · cites it directly1descendant
- K182957Heli-FX EndoAnchor SystemMedtronic Vascular, Inc. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN100026 | Aptus Steerable Endoguide with Obturator, Aptus Endostaple Applier with… | Aptus Endosystems, Inc. | 2011 | — |
| −2 | K121168 | Aptus 18FR Helifx Guide-22 Deflectable Length | Aptus Endosystems, Inc. | 2012 | — |
| −1 | K130677 | Aptus Heli-FX Aortic Securement System | Aptus Endosystems, Inc. | 2013 | — |
| 0 (this device) | K140036 | Aptus Heli-FX Guide - 22CM Deflectable Length; Aptus Heli-FX Guide - 28CM… | Aptus Endosystems, Inc. | 2014 | — |
| +1 | K141041 | Aptus Heli-FX Ancillary Endoanchor Cassette | Aptus Endosystems | 2014 | — |
| +1 | K171427 | Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette | Medtronic Vascular, Inc. | 2017 | 1 |
| +2 | K182957 | Heli-FX EndoAnchor System | Medtronic Vascular, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 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 OTD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | DEN100026 | Aptus Steerable Endoguide with Obturator, Aptus Endostaple Applier with Endostaple… Our reading of the summary gave K102333, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN100026, Aptus Steerable Endoguide with Obturator, Aptus Endostaple… (Aptus Endosystems, Inc.), granted Nov 21, 2011; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2011 |
| * | K121168 | Aptus 18FR Helifx Guide-22 Deflectable LengthSummary page 1…ssette *Aptus Heli-FX Applier *Aptus Heli-FX Guide PREDICATE DEVICES: *Aptus Heli-FX EndoAnchor System per K102333 *Aptus Heli-FX Thoracic EndoAnchor System per K(121168 *Aptus l-eli-FX EndloAnchor System and Heli-FX Thoracic EndoAnchor System per K(130677… | 2012 |
| * | K130677 | Aptus Heli-FX Aortic Securement SystemSummary page 1…FX EndoAnchor System per K102333 *Aptus Heli-FX Thoracic EndoAnchor System per K(121168 *Aptus l-eli-FX EndloAnchor System and Heli-FX Thoracic EndoAnchor System per K(130677 Page S-i Special 510(k) Submissio… | 2013 |
What descends from it? (3)
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 3 years and passes through 1 company; a new generation was cleared every 9 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K141041 (Aptus Endosystems, 2014) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate DEN100026.
How does its category compare?
All OTD devicesOTD Endovascular Suturing System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · OTD
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · OTD
Too few OTD 510(k)s in any year since 2007 to give a median.
Recalls per year · OTD
No recall names OTD since 2007.
Adverse event reports per year · OTD
53in 2025
MAUDE reports naming product code OTD, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 5 |
| 2014 | 2 | — | 0 | 16 |
| 2015 | 0 | — | 0 | 72 |
| 2016 | 0 | — | 0 | 166 |
| 2017 | 1 | — | 0 | 161 |
| 2018 | 1 | — | 0 | 215 |
| 2019 | 0 | — | 0 | 141 |
| 2020 | 0 | — | 0 | 101 |
| 2021 | 0 | — | 0 | 59 |
| 2022 | 0 | — | 0 | 52 |
| 2023 | 0 | — | 0 | 52 |
| 2024 | 0 | — | 0 | 62 |
| 2025 | 0 | — | 0 | 53 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Heli-FX EndoAnchor System is intended to provide fixation and sealing between endovascular aortic grafts and the native artery. The Heli-FX System is indicated for use in patients whose endovascular grafts have exhibited migration or endoleak, or are at risk of such complications, in whom augmented radial fixation and/or sealing is required to regain or maintain adequate aneurysm exclusion.
The EndoAnchor may be implanted at the time of the initial endograft placement, or during a secondary (i.e., repair) procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140036 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140036: Aptus Heli-FX Guide - 22CM Deflectable Length; Aptus Heli-FX Guide - 28CM Deflectable Length; Aptus Heli-FX Applier with.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140036
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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