510(k) · Cleared
ClearedAfx Introducer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endologix, Inc. · DYB Introducer, Catheter
Cleared on May 26, 2011 as substantially equivalent to K082356 (W. L. Gore & Associates, Inc., 2008) and 3 other predicates after a 134-day review. Its family tree reaches back 2 generations to 2003. 1 of the 12 devices in its family, counting itself, has a Class I recall. 7 later devices descend from it.
- Decided
- May 26, 2011
- Review
- 134 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K032073 (2003). 4 ancestors in all, the oldest K902469 (1990). 7 later devices descend from it, 1 citing it directly. 1 of the 12 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK032073 Gore Introducer Sheath with Silicone Pinch ValveW. L. Gore & Associates, Inc. · 2003
- 1 generation backK082356 Gore Introducer Sheath with Silicone Pinch ValveW. L. Gore & Associates, Inc. · 2008
- This deviceK110090 Afx Introducer SystemEndologix, Inc. · 2011
- Descendant · cites it directly · 6 of its ownK111747 Endologix Afx Introducer SystemEndologix, Inc. · 2011
- Descendant · 2 generations on · 5 of its ownK120212 Afx Introducer SystemEndologix, Inc. · 2012 · Recalled (Class I)
- Descendant · 3 generations on · 4 of its ownK141275 Endophys Pressure Sensing Sheath KitEndophys, Inc. · 2015
- Descendant · 4 generations on · 3 of its ownK160272 Endophys Pressure Sensing Sheath KitEndophys, Inc. · 2016
- Descendant · 5 generations on · 1 of its ownK173399 Endophys Pressure Sensing Sheath Kit- 8FEndophys Holdings, LLC · 2017
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K120212 Afx Introducer System2 generations on · 2012
Most influential descendants
Showing 5 of 7 · See all- K111747Endologix Afx Introducer SystemEndologix, Inc. · 2011 · cites it directly6descendants
- K120212Afx Introducer SystemEndologix, Inc. · 2012 · 2 generations on5descendants
- K141275Endophys Pressure Sensing Sheath KitEndophys, Inc. · 2015 · 3 generations on4descendants
- K160272Endophys Pressure Sensing Sheath KitEndophys, Inc. · 2016 · 4 generations on3descendants
- K173399Endophys Pressure Sensing Sheath Kit- 8FEndophys Holdings, LLC · 2017 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K032073 | Gore Introducer Sheath with Silicone Pinch Valve | W. L. Gore & Associates, Inc. | 2003 | — |
| −1 | K082356 | Gore Introducer Sheath with Silicone Pinch Valve | W. L. Gore & Associates, Inc. | 2008 | — |
| 0 (this device) | K110090 | Afx Introducer System | Endologix, Inc. | 2011 | — |
| +1 | K111747 | Endologix Afx Introducer System | Endologix, Inc. | 2011 | — |
| +2 | K120212 | Afx Introducer System | Endologix, Inc. | 2012 | Class I |
| +3 | K141275 | Endophys Pressure Sensing Sheath Kit | Endophys, Inc. | 2015 | — |
| +4 | K160272 | Endophys Pressure Sensing Sheath Kit | Endophys, Inc. | 2016 | — |
| +5 | K173399 | Endophys Pressure Sensing Sheath Kit- 8F | Endophys Holdings, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 1 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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.
1 device in this family has a Class I recall. 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? (4)
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 |
|---|---|---|---|
| * | K082356 | Gore Introducer Sheath with Silicone Pinch ValveSummary page 2…arison to the predicate devices demonstrate that the Endologix AFX Introducer System is substantially equivalent to the Gore Introducer Sheath with Silicone Pinch Valve (K082356 and K032073), the Cook Medical Extra Large Check-Flo Introducers (K902469), and the Endlologix IntuiTrak Introducer Sheath (P0400… | 2008 |
| * | K032073 | Gore Introducer Sheath with Silicone Pinch ValveSummary page 2…e predicate devices demonstrate that the Endologix AFX Introducer System is substantially equivalent to the Gore Introducer Sheath with Silicone Pinch Valve (K082356 and K032073), the Cook Medical Extra Large Check-Flo Introducers (K902469), and the Endlologix IntuiTrak Introducer Sheath (P040002/S021). Re… | 2003 |
| * | K902469 | Byrd Dilator Sheath Set - TeflonSummary page 2…cer System is substantially equivalent to the Gore Introducer Sheath with Silicone Pinch Valve (K082356 and K032073), the Cook Medical Extra Large Check-Flo Introducers (K902469), and the Endlologix IntuiTrak Introducer Sheath (P040002/S021). Refereiice is also made to the following Endologix products to s… | 1990 |
| * | P040002 | Endologix Powerlink SystemSummary page 2…cer Sheath with Silicone Pinch Valve (K082356 and K032073), the Cook Medical Extra Large Check-Flo Introducers (K902469), and the Endlologix IntuiTrak Introducer Sheath (P040002/S021). Refereiice is also made to the following Endologix products to support the clearance of the Endologix Dual Lumnen Dilator:… | 2004 |
| † | K991601 | Dual Lumen Catheter, Model DL-35-90 | 1999 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111747 | Endologix Afx Introducer System | 2011 | 6 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K120212Afx Introducer SystemEndologix, Inc. · 2012 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 5.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K111747 (Endologix, Inc., 2011) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K082356.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 AFX Introducer System facilitates the introduction of guidewires, catheters, and other medical devices into the vasculature and minimizes blood loss associated with such introduction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110090 · printed Nov 4, 2026
Cite this page
510(k) Report. “K110090: Afx Introducer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110090
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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