510(k) Report

510(k) · Cleared

Cleared

Endobionics Microsyringe (Usyringe) Infusion Catheter

K040139510(k) TraditionalCleared Feb 18, 200427-day reviewClass II21 CFR 870.1210

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

Endobionics, Inc. · KRA Catheter, Continuous Flush

Cleared on Feb 18, 2004 as substantially equivalent to K932616 (Scimed Life Systems, Inc., 1993) and 2 other predicates after a 27-day review. Its family tree reaches back 1 generation to 1991. 9 later devices descend from it.

Decided
Feb 18, 2004
Review
27 days
Class
Class II
Product code
KRA
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K913517 (1991). 3 ancestors in all. 9 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1993: 2 other ancestors2006: 1 descendant cleared2014: 1 descendant cleared2016: 2 descendants cleared2023: 2 descendants cleared2022: 1 descendant cleared2021: 1 descendant cleared2026: 1 descendant clearedK913517 · Isolate Infusion Cathetr System · Lake Region Mfg., Inc. · 19911990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 4 descendants4 generations forward: 1 descendant K913517 · Isolate Infusion Cathetr System · Lake Region Mfg., Inc. · 19910
  1. Root · 1 generation backK913517 Isolate Infusion Cathetr SystemLake Region Mfg., Inc. · 1991
  2. This deviceK040139 Endobionics Microsyringe (Usyringe) Infusion CatheterEndobionics, Inc. · 2004
  3. Descendant · cites it directly · 8 of its ownK062752 Mercator Microsyringe II Infusion CatheterMercator Medsystems, Inc. · 2006
  4. Descendant · 2 generations on · 6 of its ownK140637 Peregrine System Infusion CatheterAblative Solutions, Inc. · 2014
  5. Descendant · 2 generations on · 5 of its ownK153501 Bullfrog Micro-Infusion DeviceMercator Medsystems, Inc. · 2016
  6. Descendant · 2 generations on · 4 of its ownK161402 Bullfrog Micro-Infusion DeviceMercator Medsystems, Inc. · 2016
  7. Descendant · 3 generations on · 1 of its ownK213442 Extroducer Infusion Catheter SystemSmartWise Sweden AB · 2022

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2006: 12014: 12016: 22021: 12022: 12023: 22026: 1
2006high 2 (2016) · low 0 (2007)2026

Most influential descendants

Showing 5 of 9 · See all
  • K062752Mercator Microsyringe II Infusion CatheterMercator Medsystems, Inc. · 2006 · cites it directly8descendants
  • K140637Peregrine System Infusion CatheterAblative Solutions, Inc. · 2014 · 2 generations on6descendants
  • K153501Bullfrog Micro-Infusion DeviceMercator Medsystems, Inc. · 2016 · 2 generations on5descendants
  • K161402Bullfrog Micro-Infusion DeviceMercator Medsystems, Inc. · 2016 · 2 generations on4descendants
  • K213442Extroducer Infusion Catheter SystemSmartWise Sweden AB · 2022 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K913517Isolate Infusion Cathetr SystemLake Region Mfg., Inc.1991—
0 (this device)K040139Endobionics Microsyringe (Usyringe) Infusion CatheterEndobionics, Inc.2004—
+1K062752Mercator Microsyringe II Infusion CatheterMercator Medsystems, Inc.2006—
+2K140637Peregrine System Infusion CatheterAblative Solutions, Inc.2014—
+2K153501Bullfrog Micro-Infusion DeviceMercator Medsystems, Inc.2016—
+2K161402Bullfrog Micro-Infusion DeviceMercator Medsystems, Inc.2016—
+3K213442Extroducer Infusion Catheter SystemSmartWise Sweden AB2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199320

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
201410
201620
202110
202210
202320
202610
FIG. 1 — Lineage of K040139, 1991–2026Source: 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 KRA? 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 KRA device

  1. #1 K253509 TriSalus TriNav Advance Infusion Systemscore 14.5 · 9 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? (3)

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
*K932616Scimed (R) Dispatch (TM) Coronary Infusion Catheter
Summary page 1
…OCODE/Classification KRA/Class II Panel Cardiovascular Predicate Devices Dispatch Coronary Infusion Catheter K932616 Manufactured by SCIMED Life Systems, Inc. Selective Infusion Ii Catheter K914751 Manufactured…
Scimed Life Systems, Inc.1993—
*K914751Selective Infusion II Catheter
Summary page 1
…Dispatch Coronary Infusion Catheter K932616 Manufactured by SCIMED Life Systems, Inc. Selective Infusion Ii Catheter K914751 Manufactured by ACS/Guidant, Inc_ Isolate Infusion Catheter System K913517 Manufactured by Lake…
Advanced Cardiovascular Systems, Inc.1993—
*K913517Isolate Infusion Cathetr System
Summary page 1
…Inc. Selective Infusion Ii Catheter K914751 Manufactured by ACS/Guidant, Inc_ Isolate Infusion Catheter System K913517 Manufactured by Lake Region, Inc. Device_ escriptitn The EndoBionics pSyringe is a wire-guided endovascular catheter…
Lake Region Mfg., Inc.1991—

Also cleared against K932616: 5 other devices →

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K062752Mercator Microsyringe II Infusion CatheterMercator Medsystems, Inc.20068

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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K062752 (Mercator Medsystems, Inc., 2006) has gone furthest, with 8 descendants of its own.
  • 5 other devices also cite its predicate K932616.

How does its category compare?

All KRA devices

KRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KRA

1in 2025

2007: 52008: 72009: 52010: 22011: 22012: 32013: 32014: 42016: 82017: 42018: 42019: 42020: 62021: 62022: 62023: 72025: 12026 (partial year): 5
2007high 8 (2016) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KRA

63in 2023

2007: 44 days median2008: 144 days median2009: 69 days median2012: 29 days median2013: 126 days median2014: 61 days median2016: 122 days median2017: 166 days median2018: 178 days median2019: 133 days median2020: 29 days median2021: 108 days median2022: 228 days median2023: 63 days median2026 (partial year): 268 days median
2007high 268 (2026) · low 29 (2012)2026

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

Recalls per year · KRA

41so far in 2026, the most since 2007

2007: 22008: 62009: 82010: 262011: 32012: 32013: 22014: 3, 2 Class I2015: 12016: 3, 1 Class I2019: 4, 4 Class I2020: 12023: 22026 (partial year): 41
2007high 41 (2026) · low 0 (2017)2026

Class I (7 since 2007) Class II/III not classified

Adverse event reports per year · KRA

980in 2025

2007: 1182008: 1172009: 1872010: 3552011: 2392012: 2172013: 2092014: 2762015: 3392016: 4182017: 5382018: 4342019: 4182020: 3812021: 4402022: 5432023: 8292024: 9422025: 980
2007high 980 (2025) · low 117 (2008)2025

MAUDE reports naming product code KRA, 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
20075442118
200871446117
20095698187
20102—26355
20112—3239
20123293217
201331262209
20144613 (2)276
20150—1339
201681223 (1)418
201741660538
201841780434
201941334 (4)418
20206291381
202161080440
202262280543
20237632829
20240—0942
20251—0980
2026526841—

What is it indicated for?

In selective areas of 2.5 mm diameter peripheral and coronary vessels, the pSyringe Infusion Catheter is intended for the infusion of diagnostic and therapeutic agents that are indicated for delivery into the vessel wall or perivascular area. The pSyringe Infusion Catheter is also intended for the infusion of diagnostic and therapeutic agents intraluminally.

Indications for use as stated in the FDA summary.

Also cleared against K932616

5 other devices cite the same predicate.

  • K081147Isoflow Infusion CatheterVascular Designs, Inc. · 2009
  • K062752Mercator Microsyringe II Infusion CatheterMercator Medsystems, Inc. · 2006
  • K023548Proxis Flow-Control Device, Models Eps 101, IC 101Velocimed · 2003
  • K013635Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM Infusion Length)Bacchus Vascular, Inc. · 2002
  • K971619Microfuse Membrane Infusion CatheterE-Med Corp. · 1998

Recent decisions in KRA

The KRA category page

  • K253509TriSalus TriNav Advance Infusion SystemTrisalus Life Sciences · 2026
  • K254051Extroducer Infusion Catheter SystemSmartWise Sweden AB · 2026
  • K261610Verge™ MicrocatheterInstylla, Inc. · 2026
  • K260771TruSelect™ 2.6 MicrocatheterBoston Scientific Corporation · 2026
  • K250794InVera Infusion DeviceInvera Medical · 2026

https://510kreport.com/device/K040139 · printed Nov 4, 2026

Cite this page

510(k) Report. “K040139: Endobionics Microsyringe (Usyringe) Infusion Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040139

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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