510(k) Report

510(k) · Cleared

Recalled · 2010

Arstasis Access System

K102728510(k) SpecialCleared Oct 7, 201015-day reviewClass II21 CFR 870.1340Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Arstasis, Inc. · DYB Introducer, Catheter

Cleared on Oct 7, 2010 as substantially equivalent to K100615 (Arstasis, Inc., 2010) after a 15-day review. Its family tree reaches back 6 generations to 1995. 10 later devices descend from it. It has been recalled once.

Decided
Oct 7, 2010
Review
15 days
Class
Class II
Product code
DYB
Recalls
1
Predicates
1

Its longest line of descent runs back 6 generations to K945616 (1995). 14 ancestors in all, the oldest K915280 (1992). 10 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 3 other ancestors2004: 1 other ancestor1997: 1 other ancestor1992: 1 other ancestor1995: 2 other ancestors2011: 2 descendants cleared2012: 1 descendant cleared2013: 3 descendants cleared2014: 3 descendants cleared2015: 1 descendant clearedK945616 · Cordis Avanti Catheter Sheath Introducer · Cordis Corp. · 1995 · recalledK970392 · Cordis Avanti+Catheter Sheath Introducer System · Cordis Corp. · 1997 · recalledK050962 · Merit Prelude Sheath Introducer · Merit Medical Systems, Inc. · 2005 · recalledK070159 · Prelude Sheath Introducer · Merit Medical Systems, Inc. · 2007 · recalled×2: 2 generations cleared close together, K091006 (2010), K100615 (2010) 1990200020102020
Other ancestors, by generationDescendants, by generation 3 generations back: 3 other ancestors4 generations back: 3 other ancestors5 generations back: 1 other ancestor6 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 1 descendant5 generations forward: 2 descendants6 generations forward: 2 descendants7 generations forward: 2 descendants K100615 · Arstasis Access System · Arstasis, Inc. · 2010 · recalledK091006 · Itg Vascular Access System, Model 300 · Arstasis, Inc. · 2010 · recalledK070159 · Prelude Sheath Introducer · Merit Medical Systems, Inc. · 2007 · recalledK050962 · Merit Prelude Sheath Introducer · Merit Medical Systems, Inc. · 2005 · recalledK970392 · Cordis Avanti+Catheter Sheath Introducer System · Cordis Corp. · 1997 · recalledK945616 · Cordis Avanti Catheter Sheath Introducer · Cordis Corp. · 1995 · recalled−50+5
  1. Root · 6 generations backK945616 Cordis Avanti Catheter Sheath IntroducerCordis Corp. · 1995 · Recalled
  2. 5 generations backK970392 Cordis Avanti+Catheter Sheath Introducer SystemCordis Corp. · 1997 · Recalled
  3. 4 generations backK050962 Merit Prelude Sheath IntroducerMerit Medical Systems, Inc. · 2005 · Recalled
  4. 3 generations backK070159 Prelude Sheath IntroducerMerit Medical Systems, Inc. · 2007 · Recalled
  5. 2 generations backK091006 Itg Vascular Access System, Model 300Arstasis, Inc. · 2010 · Recalled
  6. 1 generation backK100615 Arstasis Access SystemArstasis, Inc. · 2010 · Recalled
  7. This deviceK102728 Arstasis Access SystemArstasis, Inc. · 2010
  8. Descendant · cites it directly · 9 of its ownK103143 Arstasis One Latchwire Access SystemArstasis, Inc. · 2011
  9. Descendant · 2 generations on · 8 of its ownK113110 Axera Access SystemArstasis, Inc. · 2011
  10. Descendant · 3 generations on · 7 of its ownK121521 Axera Access SystemArstasis, Inc. · 2012
  11. Descendant · 4 generations on · 6 of its ownK123135 Axera 2 Access System Model AXE200Arstasis, Inc. · 2013
  12. Descendant · 5 generations on · 5 of its ownK123618 Axera 2 Access SystemArstasis, Inc. · 2013

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2011: 22012: 12013: 32014: 32015: 1
2011high 3 (2013) · low 0 (2016)2026

Most influential descendants

Showing 5 of 10 · See all
  • K103143Arstasis One Latchwire Access SystemArstasis, Inc. · 2011 · cites it directly9descendants
  • K113110Axera Access SystemArstasis, Inc. · 2011 · 2 generations on8descendants
  • K121521Axera Access SystemArstasis, Inc. · 2012 · 3 generations on7descendants
  • K123135Axera 2 Access System Model AXE200Arstasis, Inc. · 2013 · 4 generations on6descendants
  • K123618Axera 2 Access SystemArstasis, Inc. · 2013 · 5 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K945616Cordis Avanti Catheter Sheath IntroducerCordis Corp.19951
−5K970392Cordis Avanti+Catheter Sheath Introducer SystemCordis Corp.19972
−4K050962Merit Prelude Sheath IntroducerMerit Medical Systems, Inc.20051
−3K070159Prelude Sheath IntroducerMerit Medical Systems, Inc.20073
−2K091006Itg Vascular Access System, Model 300Arstasis, Inc.20101
−1K100615Arstasis Access SystemArstasis, Inc.20101
0 (this device)K102728Arstasis Access SystemArstasis, Inc.2010—
+1K103143Arstasis One Latchwire Access SystemArstasis, Inc.2011—
+2K113110Axera Access SystemArstasis, Inc.2011—
+3K121521Axera Access SystemArstasis, Inc.2012—
+4K123135Axera 2 Access System Model AXE200Arstasis, Inc.2013—
+5K123618Axera 2 Access SystemArstasis, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199520
199710
200410
200630

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201120
201210
201330
201430
201510
FIG. 1 — Lineage of K102728, 1995–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K251051 AuST Steerable Sheathscore 18.0 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K100615Arstasis Access System
Summary page 1
…Regulation Number: 21 CFR 870.1340 Classification Name: Catheter Introducer Product Code: DYB Predicate Device: Arstas ison t Access System (K 100615) Device Description: Arstasis... is a device that is comprised of a sheath, anchor mechanism, shaf…
Arstasis, Inc.20101

What descends from it? (10)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K103143Arstasis One Latchwire Access SystemArstasis, Inc.20119

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Oct 19, 2010Not classifiedZ-0993-2011Device DesignDevice has the potential to fracture and sheath separation during use.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
  • 8 of the 14 ancestors have a recall of any class.
  • Of its descendants, K103143 (Arstasis, Inc., 2011) has gone furthest, with 9 descendants of its own.

How does its category compare?

All DYB devices

DYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · DYB

16in 2025

2007: 122008: 172009: 142010: 182011: 172012: 222013: 262014: 302015: 172016: 192017: 242018: 192019: 182020: 92021: 122022: 132023: 152024: 182025: 162026 (partial year): 17
2007high 30 (2014) · low 9 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DYB

63in 2025

2007: 95 days median2008: 37 days median2009: 52 days median2010: 123 days median2011: 100 days median2012: 128 days median2013: 118 days median2014: 122 days median2015: 129 days median2016: 95 days median2017: 70 days median2018: 156 days median2019: 47 days median2020: 49 days median2021: 78 days median2022: 143 days median2023: 55 days median2024: 56 days median2025: 63 days median2026 (partial year): 59 days median
2007high 156 (2018) · low 37 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DYB

3in 2025

2007: 152008: 92009: 252010: 182011: 42012: 32013: 5, 1 Class I2014: 22015: 2, 1 Class I2016: 45, 3 Class I2017: 22, 1 Class I2018: 12019: 22020: 21, 21 Class I2021: 62022: 22023: 102024: 22025: 32026 (partial year): 23, 21 Class I
2007high 45 (2016) · low 1 (2018)2026

Class I (48 since 2007) Class II/III not classified

Adverse event reports per year · DYB

4,539in 2025

2007: 3162008: 4232009: 3992010: 4452011: 6282012: 8982013: 7432014: 7802015: 9132016: 1,2342017: 1,6722018: 1,9032019: 2,4502020: 2,4652021: 2,8352022: 4,0842023: 3,7752024: 3,9312025: 4,539
2007high 4,539 (2025) · low 316 (2007)2025

MAUDE reports naming product code DYB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007129515316
200817379423
2009145225399
20101812318445
2011171004628
2012221283898
2013261185 (1)743
2014301222780
2015171292 (1)913
2016199545 (3)1,234
2017247022 (1)1,672
20181915611,903
2019184722,450
202094921 (21)2,465
2021127862,835
20221314324,084
20231555103,775
2024185623,931
2025166334,539
2026175923 (21)—

What is it indicated for?

The Arstasisone 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. The Arstasiswe Access System is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using SF or 6F introducer sheaths.

Indications for use as stated in the FDA summary.

More from Arstasis, Inc.

14 FDA decisions under this applicant name. See the company

  • K151877MicroTract Access SystemArstasis, Inc. · 2015
  • K140871Axera 2 Access SystemArstasis, Inc. · 2014
  • K140287Axera RX Access SystemArstasis, Inc. · 2014
  • K140201Axera 2 Access SystemArstasis, Inc. · 2014
  • K132263Axera 2 Access SystemArstasis, Inc. · 2013

Recent decisions in DYB

The DYB category page

  • K262674Giranel Guiding Sheath SetKossel Medtech (Suzhou) Co., Ltd. · 2026
  • K253526NAMIC Dilator and SheathMedline Industries, LP · 2026
  • K261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit /…Hartman Medical Group, LLC · 2026
  • K261242SimplGuidePendracare · 2026
  • K261950Health Line Tearaway IntroducerHealth Line International Corporation · 2026

https://510kreport.com/device/K102728 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102728: Arstasis 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/K102728

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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