510(k) · Cleared
ClearedMicroTract Access System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arstasis, Inc. · DRE Dilator, Vessel, For Percutaneous Catheterization
Cleared on Aug 7, 2015 as substantially equivalent to K103421 (Arstasis, Inc., 2011) and 1 other predicate after a 29-day review. Its family tree reaches back 14 generations to 1995.
- Decided
- Aug 7, 2015
- Review
- 29 days
- Class
- Class II
- Product code
- DRE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K945616 (1995). 24 ancestors in all, the oldest K915280 (1992). No later device cites it as a predicate yet.
- Root · 14 generations backK945616 Cordis Avanti Catheter Sheath IntroducerCordis Corp. · 1995 · Recalled
- 10 generations between
- 3 generations backK123618 Axera 2 Access SystemArstasis, Inc. · 2013
- 2 generations backK132263 Axera 2 Access SystemArstasis, Inc. · 2013
- 1 generation backK140287 Axera RX Access SystemArstasis, Inc. · 2014
- This deviceK151877 MicroTract Access SystemArstasis, Inc. · 2015
Show all 14 generations
- Root · 14 generations backK945616 Cordis Avanti Catheter Sheath IntroducerCordis Corp. · 1995 · Recalled
- 13 generations backK970392 Cordis Avanti+Catheter Sheath Introducer SystemCordis Corp. · 1997 · Recalled
- 12 generations backK050962 Merit Prelude Sheath IntroducerMerit Medical Systems, Inc. · 2005 · Recalled
- 11 generations backK070159 Prelude Sheath IntroducerMerit Medical Systems, Inc. · 2007 · Recalled
- 10 generations backK091006 Itg Vascular Access System, Model 300Arstasis, Inc. · 2010 · Recalled
- 9 generations backK100615 Arstasis Access SystemArstasis, Inc. · 2010 · Recalled
- 8 generations backK102728 Arstasis Access SystemArstasis, Inc. · 2010 · Recalled
- 7 generations backK103143 Arstasis One Latchwire Access SystemArstasis, Inc. · 2011
- 6 generations backK113110 Axera Access SystemArstasis, Inc. · 2011
- 5 generations backK121521 Axera Access SystemArstasis, Inc. · 2012
- 4 generations backK123135 Axera 2 Access System Model AXE200Arstasis, Inc. · 2013
- 3 generations backK123618 Axera 2 Access SystemArstasis, Inc. · 2013
- 2 generations backK132263 Axera 2 Access SystemArstasis, Inc. · 2013
- 1 generation backK140287 Axera RX Access SystemArstasis, Inc. · 2014
- This deviceK151877 MicroTract Access SystemArstasis, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K945616 | Cordis Avanti Catheter Sheath Introducer | Cordis Corp. | 1995 | 1 |
| −13 | K970392 | Cordis Avanti+Catheter Sheath Introducer System | Cordis Corp. | 1997 | 2 |
| −12 | K050962 | Merit Prelude Sheath Introducer | Merit Medical Systems, Inc. | 2005 | 1 |
| −11 | K070159 | Prelude Sheath Introducer | Merit Medical Systems, Inc. | 2007 | 3 |
| −10 | K091006 | Itg Vascular Access System, Model 300 | Arstasis, Inc. | 2010 | 1 |
| −9 | K100615 | Arstasis Access System | Arstasis, Inc. | 2010 | 1 |
| −8 | K102728 | Arstasis Access System | Arstasis, Inc. | 2010 | 1 |
| −7 | K103143 | Arstasis One Latchwire Access System | Arstasis, Inc. | 2011 | — |
| −6 | K113110 | Axera Access System | Arstasis, Inc. | 2011 | — |
| −5 | K121521 | Axera Access System | Arstasis, Inc. | 2012 | — |
| −4 | K123135 | Axera 2 Access System Model AXE200 | Arstasis, Inc. | 2013 | — |
| −3 | K123618 | Axera 2 Access System | Arstasis, Inc. | 2013 | — |
| −2 | K132263 | Axera 2 Access System | Arstasis, Inc. | 2013 | — |
| −1 | K140287 | Axera RX Access System | Arstasis, Inc. | 2014 | — |
| 0 (this device) | K151877 | MicroTract Access System | Arstasis, Inc. | 2015 | — |
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 |
| 2011 | 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 DRE? 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 DRE device
- #1 K261310 FlexTract Deflectable-Rotational Dilator…score 12.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K103421 | Arstasis Dilator AdapterSummary page 4…CFR 870.1310 Classification Name: dilator, vessel, for percutaneous catheterization Product Code: DRE Primary Predicate Arstasis Dilator Adapter (K103421) Device: Secondary Predicate AXERA RX Access System (K140287) Device: Device Description: The MicroTract Access System… | 2011 |
| * | K140287 | Axera RX Access SystemSummary page 4…taneous catheterization Product Code: DRE Primary Predicate Arstasis Dilator Adapter (K103421) Device: Secondary Predicate AXERA RX Access System (K140287) Device: Device Description: The MicroTract Access System contains a 20 gauge Access Needle, a 0.0… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 20 years and passes through 3 companies; a new generation was cleared every 9 months on median.
- 9 of the 24 ancestors have a recall of any class.
How does its category compare?
All DRE devicesDRE Dilator, Vessel, For Percutaneous Catheterization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · DRE
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRE
31in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRE
1in 2016
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DRE
356in 2025
MAUDE reports naming product code DRE, 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 | 5 | 160 | 0 | 81 |
| 2008 | 2 | — | 0 | 38 |
| 2009 | 2 | — | 2 | 69 |
| 2010 | 1 | — | 2 | 73 |
| 2011 | 1 | — | 1 | 90 |
| 2012 | 1 | — | 0 | 132 |
| 2013 | 4 | 111 | 0 | 120 |
| 2014 | 6 | 72 | 0 | 82 |
| 2015 | 4 | 30 | 1 | 82 |
| 2016 | 3 | 90 | 1 | 84 |
| 2017 | 4 | 108 | 0 | 101 |
| 2018 | 2 | — | 0 | 126 |
| 2019 | 3 | 68 | 0 | 144 |
| 2020 | 3 | 30 | 0 | 120 |
| 2021 | 1 | — | 0 | 115 |
| 2022 | 3 | 261 | 0 | 136 |
| 2023 | 2 | — | 0 | 386 |
| 2024 | 1 | — | 0 | 325 |
| 2025 | 3 | 31 | 0 | 356 |
| 2026 | 1 | — | 1 (1) | — |
What is it indicated for?
The MicroTract Access System is intended to allow the use of a
.018” guidewire with a .035” or .038” guidewire compatible dilator up to 23cm in overall length.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151877 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151877: MicroTract 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/K151877
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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