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 24, 2013 as substantially equivalent to K123135 (Arstasis, Inc., 2013) and 3 other predicates after a 121-day review. Its family tree reaches back 11 generations to 1995. 5 later devices descend from it.
- Decided
- Mar 24, 2013
- Review
- 121 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 11 generations to K945616 (1995). 20 ancestors in all, the oldest K915280 (1992). 5 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK945616 Cordis Avanti Catheter Sheath IntroducerCordis Corp. · 1995 · Recalled
- 7 generations between
- 3 generations backK113110 Axera Access SystemArstasis, Inc. · 2011
- 2 generations backK121521 Axera Access SystemArstasis, Inc. · 2012
- 1 generation backK123135 Axera 2 Access System Model AXE200Arstasis, Inc. · 2013
- This deviceK123618 Axera 2 Access SystemArstasis, Inc. · 2013
- Descendant · cites it directly · 4 of its ownK132263 Axera 2 Access SystemArstasis, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK140287 Axera RX Access SystemArstasis, Inc. · 2014
- Descendant · 2 generations on · 1 of its ownK140201 Axera 2 Access SystemArstasis, Inc. · 2014
- Descendant · 3 generations on · 0 of its ownK151877 MicroTract Access SystemArstasis, Inc. · 2015
- Descendant · 3 generations on · 0 of its ownK140871 Axera 2 Access SystemArstasis, Inc. · 2014
Show all 11 generations
- Root · 11 generations backK945616 Cordis Avanti Catheter Sheath IntroducerCordis Corp. · 1995 · Recalled
- 10 generations backK970392 Cordis Avanti+Catheter Sheath Introducer SystemCordis Corp. · 1997 · Recalled
- 9 generations backK050962 Merit Prelude Sheath IntroducerMerit Medical Systems, Inc. · 2005 · Recalled
- 8 generations backK070159 Prelude Sheath IntroducerMerit Medical Systems, Inc. · 2007 · Recalled
- 7 generations backK091006 Itg Vascular Access System, Model 300Arstasis, Inc. · 2010 · Recalled
- 6 generations backK100615 Arstasis Access SystemArstasis, Inc. · 2010 · Recalled
- 5 generations backK102728 Arstasis Access SystemArstasis, Inc. · 2010 · Recalled
- 4 generations backK103143 Arstasis One Latchwire Access SystemArstasis, Inc. · 2011
- 3 generations backK113110 Axera Access SystemArstasis, Inc. · 2011
- 2 generations backK121521 Axera Access SystemArstasis, Inc. · 2012
- 1 generation backK123135 Axera 2 Access System Model AXE200Arstasis, Inc. · 2013
- This deviceK123618 Axera 2 Access SystemArstasis, Inc. · 2013
Most influential descendants
Showing 5 of 5 · See all- K132263Axera 2 Access SystemArstasis, Inc. · 2013 · cites it directly4descendants
- K140287Axera RX Access SystemArstasis, Inc. · 2014 · 2 generations on1descendant
- K140201Axera 2 Access SystemArstasis, Inc. · 2014 · 2 generations on1descendant
- K151877MicroTract Access SystemArstasis, Inc. · 2015 · 3 generations on0descendants
- K140871Axera 2 Access SystemArstasis, Inc. · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K945616 | Cordis Avanti Catheter Sheath Introducer | Cordis Corp. | 1995 | 1 |
| −10 | K970392 | Cordis Avanti+Catheter Sheath Introducer System | Cordis Corp. | 1997 | 2 |
| −9 | K050962 | Merit Prelude Sheath Introducer | Merit Medical Systems, Inc. | 2005 | 1 |
| −8 | K070159 | Prelude Sheath Introducer | Merit Medical Systems, Inc. | 2007 | 3 |
| −7 | K091006 | Itg Vascular Access System, Model 300 | Arstasis, Inc. | 2010 | 1 |
| −6 | K100615 | Arstasis Access System | Arstasis, Inc. | 2010 | 1 |
| −5 | K102728 | Arstasis Access System | Arstasis, Inc. | 2010 | 1 |
| −4 | K103143 | Arstasis One Latchwire Access System | Arstasis, Inc. | 2011 | — |
| −3 | K113110 | Axera Access System | Arstasis, Inc. | 2011 | — |
| −2 | K121521 | Axera Access System | Arstasis, Inc. | 2012 | — |
| −1 | K123135 | Axera 2 Access System Model AXE200 | Arstasis, Inc. | 2013 | — |
| 0 (this device) | K123618 | Axera 2 Access System | Arstasis, Inc. | 2013 | — |
| +1 | K132263 | Axera 2 Access System | Arstasis, Inc. | 2013 | — |
| +2 | K140287 | Axera RX Access System | Arstasis, Inc. | 2014 | — |
| +2 | K140201 | Axera 2 Access System | Arstasis, Inc. | 2014 | — |
| +3 | K151877 | MicroTract Access System | Arstasis, Inc. | 2015 | — |
| +3 | 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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 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? (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 |
|---|---|---|---|
| * | K123135 | Axera 2 Access System Model AXE200 Cleared while this submission was under review Summary page 1…s II Regulation Number: 21 CER 870.1340 Classification Name: Catheter Introducer Product Code: DYB Predicate Device: AXERA 2 Access System (K123 135) manufactured by Arstasis, Inc., Prelude Sheath Introducer (K(070159) manufactured by Merit… | 2013 |
| * | K070159 | Prelude Sheath IntroducerSummary page 1…uct Code: DYB Predicate Device: AXERA 2 Access System (K123 135) manufactured by Arstasis, Inc., Prelude Sheath Introducer (K(070159) manufactured by Merit Medical Systems, Inc.; Pinnacle Introducer Sheath (K984260)… | 2007 |
| * | K984260 | Pinnacle R/O or Redifocus Introducer R/O (Comprised of a Sheath & Dilator)Summary page 1…is, Inc., Prelude Sheath Introducer (K(070159) manufactured by Merit Medical Systems, Inc.; Pinnacle Introducer Sheath (K984260) manufactured by Terumo Medical Corporation; and Avanti Catheter Sheath Introdu… | 1999 |
| * | K945616 | Cordis Avanti Catheter Sheath IntroducerSummary page 1…nnacle Introducer Sheath (K984260) manufactured by Terumo Medical Corporation; and Avanti Catheter Sheath Introducer (K(945616) manufactured by Cordis Corporation. Device Description: The AX.ERA 2 is a device that is compris… | 1995 |
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 |
|---|---|---|---|
| K132263 | Axera 2 Access System | 2013 | 4 |
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 18 years and passes through 3 companies; a new generation was cleared every 7 months on median.
- 9 of the 20 ancestors have a recall of any class.
- Of its descendants, K132263 (Arstasis, Inc., 2013) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K123135.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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/K123618 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123618: Axera 2 Access System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123618
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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