510(k) · Cleared

Cleared

Aptus 18FR Helifx Guide-22 Deflectable Length

K121168510(k) TraditionalCleared Aug 8, 2012113-day reviewClass II21 CFR 870.3460

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Aptus Endosystems, Inc. · OTD Endovascular Suturing System

Cleared on Aug 8, 2012 as substantially equivalent to DEN100026 (Aptus Endosystems, Inc., 2011) after a 113-day review. Its family tree reaches back 1 generation to 2011. 5 later devices descend from it.

Decided: Aug 8, 2012
Review: 113 days
Class: Class II
Product code: OTD
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to DEN100026 (2011). 5 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backDEN100026 Aptus Steerable Endoguide with Obturator, Aptus Endostaple Applier…Aptus Endosystems, Inc. · 2011
This deviceK121168 Aptus 18FR Helifx Guide-22 Deflectable LengthAptus Endosystems, Inc. · 2012
Descendant · cites it directly · 4 of its ownK130677 Aptus Heli-FX Aortic Securement SystemAptus Endosystems, Inc. · 2013
Descendant · cites it directly · 3 of its ownK140036 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 5 of 5 · See all

K130677Aptus Heli-FX Aortic Securement SystemAptus Endosystems, Inc. · 2013 · cites it directly4descendants
K140036Aptus Heli-FX Guide - 22CM Deflectable Length; Aptus Heli-FX Guide - 28CM Deflectable…Aptus Endosystems, Inc. · 2014 · cites it directly3descendants
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
−1	DEN100026	Aptus Steerable Endoguide with Obturator, Aptus Endostaple Applier with…	Aptus Endosystems, Inc.	2011	—
0 (this device)	K121168	Aptus 18FR Helifx Guide-22 Deflectable Length	Aptus Endosystems, Inc.	2012	—
+1	K130677	Aptus Heli-FX Aortic Securement System	Aptus Endosystems, Inc.	2013	—
+1	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
2013	1	0
2014	2	0
2017	1	0
2018	1	0

FIG. 1 — Lineage of K121168, 2011–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	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.	Aptus Endosystems, Inc.	2011	—

Also cleared against DEN100026: 4 other devices →

What descends from it? (5)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K130677	Aptus Heli-FX Aortic Securement System	Aptus Endosystems, Inc.	2013	4
K140036	Aptus Heli-FX Guide - 22CM Deflectable Length; Aptus Heli-FX Guide - 28CM Deflectable…	Aptus Endosystems, Inc.	2014	3
K141041	Aptus Heli-FX Ancillary Endoanchor Cassette	Aptus Endosystems	2014	2
K171427	Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette	Medtronic Vascular, Inc.	2017	1

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?

Its one ancestor has no recall.
Of its descendants, K130677 (Aptus Endosystems, Inc., 2013) has gone furthest, with 4 descendants of its own.
4 other devices also cite its predicate DEN100026.

How does its category compare?

All OTD devices

OTD Endovascular Suturing System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · OTD

1in 2018

2007high 2 (2014) · low 0 (2007)2026

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

2007high 215 (2018) · low 0 (2007)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	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	1	—	0
2012	1	—	1
2013	1	—	5
2014	2	—	16
2015	0	—	72
2016	0	—	166
2017	1	—	161
2018	1	—	215
2019	0	—	141
2020	0	—	101
2021	0	—	59
2022	0	—	52
2023	0	—	52
2024	0	—	62
2025	0	—	53
2026	0	—	—

What is it indicated for?

The Aptus 18Fr HeliFX Aortic Securement System is intended to provide fixation and sealing between endlovascular aortic grafts and the native artery. The 18Fr HeliFX System is indicated for use in patients whose endlovascular 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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K121168 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121168: Aptus 18FR Helifx Guide-22 Deflectable Length.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121168

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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