510(k) · Cleared
ClearedAxera 2 Access System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arstasis, Inc. · DYB Introducer, Catheter
Cleared on Mar 28, 2014 as substantially equivalent to K132263 (Arstasis, Inc., 2013) after a 60-day review. Its family tree reaches back 13 generations to 1995. 1 later device descends from it.
- Decided
- Mar 28, 2014
- Review
- 60 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K945616 (1995). 22 ancestors in all, the oldest K915280 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 13 generations backK945616 Cordis Avanti Catheter Sheath IntroducerCordis Corp. · 1995 · Recalled
- 9 generations between
- 3 generations backK123135 Axera 2 Access System Model AXE200Arstasis, Inc. · 2013
- 2 generations backK123618 Axera 2 Access SystemArstasis, Inc. · 2013
- 1 generation backK132263 Axera 2 Access SystemArstasis, Inc. · 2013
- This deviceK140201 Axera 2 Access SystemArstasis, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK140871 Axera 2 Access SystemArstasis, Inc. · 2014
Show all 13 generations
- Root · 13 generations backK945616 Cordis Avanti Catheter Sheath IntroducerCordis Corp. · 1995 · Recalled
- 12 generations backK970392 Cordis Avanti+Catheter Sheath Introducer SystemCordis Corp. · 1997 · Recalled
- 11 generations backK050962 Merit Prelude Sheath IntroducerMerit Medical Systems, Inc. · 2005 · Recalled
- 10 generations backK070159 Prelude Sheath IntroducerMerit Medical Systems, Inc. · 2007 · Recalled
- 9 generations backK091006 Itg Vascular Access System, Model 300Arstasis, Inc. · 2010 · Recalled
- 8 generations backK100615 Arstasis Access SystemArstasis, Inc. · 2010 · Recalled
- 7 generations backK102728 Arstasis Access SystemArstasis, Inc. · 2010 · Recalled
- 6 generations backK103143 Arstasis One Latchwire Access SystemArstasis, Inc. · 2011
- 5 generations backK113110 Axera Access SystemArstasis, Inc. · 2011
- 4 generations backK121521 Axera Access SystemArstasis, Inc. · 2012
- 3 generations backK123135 Axera 2 Access System Model AXE200Arstasis, Inc. · 2013
- 2 generations backK123618 Axera 2 Access SystemArstasis, Inc. · 2013
- 1 generation backK132263 Axera 2 Access SystemArstasis, Inc. · 2013
- This deviceK140201 Axera 2 Access SystemArstasis, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K140871Axera 2 Access SystemArstasis, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K945616 | Cordis Avanti Catheter Sheath Introducer | Cordis Corp. | 1995 | 1 |
| −12 | K970392 | Cordis Avanti+Catheter Sheath Introducer System | Cordis Corp. | 1997 | 2 |
| −11 | K050962 | Merit Prelude Sheath Introducer | Merit Medical Systems, Inc. | 2005 | 1 |
| −10 | K070159 | Prelude Sheath Introducer | Merit Medical Systems, Inc. | 2007 | 3 |
| −9 | K091006 | Itg Vascular Access System, Model 300 | Arstasis, Inc. | 2010 | 1 |
| −8 | K100615 | Arstasis Access System | Arstasis, Inc. | 2010 | 1 |
| −7 | K102728 | Arstasis Access System | Arstasis, Inc. | 2010 | 1 |
| −6 | K103143 | Arstasis One Latchwire Access System | Arstasis, Inc. | 2011 | — |
| −5 | K113110 | Axera Access System | Arstasis, Inc. | 2011 | — |
| −4 | K121521 | Axera Access System | Arstasis, Inc. | 2012 | — |
| −3 | K123135 | Axera 2 Access System Model AXE200 | Arstasis, Inc. | 2013 | — |
| −2 | K123618 | Axera 2 Access System | Arstasis, Inc. | 2013 | — |
| −1 | K132263 | Axera 2 Access System | Arstasis, Inc. | 2013 | — |
| 0 (this device) | K140201 | Axera 2 Access System | Arstasis, Inc. | 2014 | — |
| +1 | K140871 | Axera 2 Access System | Arstasis, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 DYB? 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 |
|---|---|---|---|
| * | K132263 | Axera 2 Access SystemSummary page 1…I1 Regulation Number: 21 CER 870.1340 Classification Name: Catheter Introducer Product Code: DYB Predicate Device: AXERA'2 Access System (1(132263) Device Description: The AXERA 2 is a device that is comprised of a Latchwire, anchor mechanism, sh… | 2013 |
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 |
|---|---|---|---|
| K140871 | Axera 2 Access System | 2014 | 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 19 years and passes through 3 companies; a new generation was cleared every 7 months on median.
- 9 of the 22 ancestors have a recall of any class.
- Of its descendants, K140871 (Arstasis, Inc., 2014) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K132263.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 AXERA Access System is intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. AXERA is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140201 · printed Nov 3, 2026
Cite this page
510(k) Report. “K140201: Axera 2 Access System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K140201
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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