510(k) · Cleared
Recalled · Class I · 2013Afx 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 Feb 9, 2012 as substantially equivalent to K111747 (Endologix, Inc., 2011) after a 16-day review. Its family tree reaches back 4 generations to 2003. 1 of the 12 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Feb 9, 2012
- Review
- 16 days
- Class
- Class II
- Product code
- DYB
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 4 generations to K032073 (2003). 6 ancestors in all, the oldest K902469 (1990). 5 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 · 4 generations backK032073 Gore Introducer Sheath with Silicone Pinch ValveW. L. Gore & Associates, Inc. · 2003
- 3 generations backK082356 Gore Introducer Sheath with Silicone Pinch ValveW. L. Gore & Associates, Inc. · 2008
- 2 generations backK110090 Afx Introducer SystemEndologix, Inc. · 2011
- 1 generation backK111747 Endologix Afx Introducer SystemEndologix, Inc. · 2011
- This deviceK120212 Afx Introducer SystemEndologix, Inc. · 2012
- Descendant · cites it directly · 4 of its ownK141275 Endophys Pressure Sensing Sheath KitEndophys, Inc. · 2015
- Descendant · 2 generations on · 3 of its ownK160272 Endophys Pressure Sensing Sheath KitEndophys, Inc. · 2016
- Descendant · 3 generations on · 1 of its ownK173399 Endophys Pressure Sensing Sheath Kit- 8FEndophys Holdings, LLC · 2017
- Descendant · 4 generations on · 0 of its ownK190098 Endophys Pressure Sensing SheathEndophys Holdings, LLC · 2019
- Descendant · 3 generations on · 0 of its ownK180620 Endophys Pressure Sensing Sheath KitEndophys Holdings, LLC · 2018
Most influential descendants
Showing 5 of 5 · See all- K141275Endophys Pressure Sensing Sheath KitEndophys, Inc. · 2015 · cites it directly4descendants
- K160272Endophys Pressure Sensing Sheath KitEndophys, Inc. · 2016 · 2 generations on3descendants
- K173399Endophys Pressure Sensing Sheath Kit- 8FEndophys Holdings, LLC · 2017 · 3 generations on1descendant
- K190098Endophys Pressure Sensing SheathEndophys Holdings, LLC · 2019 · 4 generations on0descendants
- K180620Endophys Pressure Sensing Sheath KitEndophys Holdings, LLC · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K032073 | Gore Introducer Sheath with Silicone Pinch Valve | W. L. Gore & Associates, Inc. | 2003 | — |
| −3 | K082356 | Gore Introducer Sheath with Silicone Pinch Valve | W. L. Gore & Associates, Inc. | 2008 | — |
| −2 | K110090 | Afx Introducer System | Endologix, Inc. | 2011 | — |
| −1 | K111747 | Endologix Afx Introducer System | Endologix, Inc. | 2011 | — |
| 0 (this device) | K120212 | Afx Introducer System | Endologix, Inc. | 2012 | — |
| +1 | K141275 | Endophys Pressure Sensing Sheath Kit | Endophys, Inc. | 2015 | — |
| +2 | K160272 | Endophys Pressure Sensing Sheath Kit | Endophys, Inc. | 2016 | — |
| +3 | K173399 | Endophys Pressure Sensing Sheath Kit- 8F | Endophys Holdings, LLC | 2017 | — |
| +4 | K190098 | Endophys Pressure Sensing Sheath | Endophys Holdings, LLC | 2019 | — |
| +3 | K180620 | Endophys Pressure Sensing Sheath Kit | Endophys Holdings, LLC | 2018 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K111747 | Endologix Afx Introducer SystemSummary page 2…hat the introducer sheath can be placed within the vasculature during standard vascular access. There are no changes to the dilator from that cleared under K111747. Peel-away Wire Straightener: A newly added peel-away wire straightener has been added to the AFX Introducer Syste… | 2011 |
| † | P040002 | Endologix Powerlink System | 2004 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141275 | Endophys Pressure Sensing Sheath Kit | 2015 | 4 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 13, 2013 | Class I | Z-1436-2013 | Nonconforming Material/Component | Endologix, Inc. initiated this voluntary recall of certain lots of Endologix, Inc. due to reports of dilator breakage during clinical procedures. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K141275 (Endophys, Inc., 2015) has gone furthest, with 4 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. 2012, 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 Endologix AFX Introducer System is intended for use to facilitate the introduction of guidewires, catheters, and other medical devices into the vasculature and minimize blood loss associated with such introduction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120212 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120212: 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/K120212
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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