510(k) Report

510(k) · Cleared

Cleared

Scimed (R) Dispatch (TM) Coronary Infusion Catheter

K932616510(k) TraditionalCleared Dec 15, 1993197-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

Scimed Life Systems, Inc. · KRA Catheter, Continuous Flush

Cleared on Dec 15, 1993 after a 197-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 113 devices in its family, counting itself, have a Class I recall. 112 later devices descend from it.

Decided
Dec 15, 1993
Review
197 days
Class
Class II
Product code
KRA
Recalls
None
Predicates
0

112 later devices descend from it, 6 citing it directly. 2 of the 113 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 2003: 4 descendants cleared1998: 1 descendant cleared2009: 1 descendant cleared2004: 7 descendants cleared2002: 3 descendants cleared2006: 10 descendants cleared2008: 10 descendants cleared2014: 3 descendants cleared2005: 11 descendants cleared2016: 6 descendants cleared2013: 2 descendants cleared, 1 with a Class I recall12007: 8 descendants cleared, 1 with a Class I recall12023: 6 descendants cleared2020: 6 descendants cleared2022: 4 descendants cleared2021: 3 descendants cleared2012: 2 descendants cleared2024: 5 descendants cleared2026: 8 descendants cleared2018: 3 descendants cleared2025: 3 descendants cleared2017: 1 descendant cleared2011: 1 descendant cleared2019: 4 descendants cleared1990200020102020
  1. This deviceK932616 Scimed (R) Dispatch (TM) Coronary Infusion CatheterScimed Life Systems, Inc. · 1993
  2. Descendant · cites it directly · 75 of its ownK013635 Trellis Infusion System (10CM Infusion Length); Trellis Infusion…Bacchus Vascular, Inc. · 2002
  3. Descendant · 2 generations on · 57 of its ownK021958 Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion…Bacchus Vascular, Inc. · 2002 · Recalled
  4. Descendant · 2 generations on · 56 of its ownK023514 Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM…Bacchus Vascular, Inc. · 2002 · Recalled
  5. Descendant · 3 generations on · 50 of its ownK030637 Ekos Peripheral Infusion SystemEkos Corp. · 2003
  6. Descendant · 4 generations on · 46 of its ownK033214 Ekos Peripheral Infusion SystemEkos Corp. · 2003

Showing 5 of 112 descendants. See all descendants

Descendants cleared per year

1998: 12002: 32003: 42004: 72005: 112006: 102007: 82008: 102009: 12011: 12012: 22013: 22014: 32016: 62017: 12018: 32019: 42020: 62021: 32022: 42023: 62024: 52025: 32026: 8
1998high 11 (2005) · low 0 (1999)2026

Class I recalls in this family

  • K071664 Trellis-6 Peripheral Infusion System5 generations on · 2007
  • K130904 Trellis-8 Peripheral Infusion System5 generations on · 2013

Most influential descendants

Showing 5 of 112 · See all
  • K013635Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM Infusion…Bacchus Vascular, Inc. · 2002 · cites it directly75descendants
  • K021958Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM (100CM…Bacchus Vascular, Inc. · 2002 · 2 generations on57descendants
  • K023514Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion Length)Bacchus Vascular, Inc. · 2002 · 2 generations on56descendants
  • K030637Ekos Peripheral Infusion SystemEkos Corp. · 2003 · 3 generations on50descendants
  • K033214Ekos Peripheral Infusion SystemEkos Corp. · 2003 · 4 generations on46descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K932616Scimed (R) Dispatch (TM) Coronary Infusion CatheterScimed Life Systems, Inc.1993—
+1K013635Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM…Bacchus Vascular, Inc.2002—
+2K021958Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM…Bacchus Vascular, Inc.20021
+2K023514Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion…Bacchus Vascular, Inc.20021
+3K030637Ekos Peripheral Infusion SystemEkos Corp.2003—
+4K033214Ekos Peripheral Infusion SystemEkos Corp.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200230
200340
200470
2005110
2006100
200781
2008100
200910
201110
201220
201321
201430
201660
201710
201830
201940
202060
202130
202240
202360
202450
202530
202680
FIG. 1 — Lineage of K932616, 1993–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

2 devices in this family have a Class I recall. 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 14.4 · 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (112)

See all 112

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K013635Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM Infusion…Bacchus Vascular, Inc.200275
K971619Microfuse Membrane Infusion CatheterE-Med Corp.199818
K040139Endobionics Microsyringe (Usyringe) Infusion CatheterEndobionics, Inc.20049
K062752Mercator Microsyringe II Infusion CatheterMercator Medsystems, Inc.20068
K023548Proxis Flow-Control Device, Models Eps 101, IC 101Velocimed20036
K081147Isoflow Infusion CatheterVascular Designs, Inc.20091

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K071664Trellis-6 Peripheral Infusion SystemBacchus Vascular, Inc. · 2007 · 5 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
  • K130904Trellis-8 Peripheral Infusion SystemCovidien · 2013 · 5 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K013635 (Bacchus Vascular, Inc., 2002) has gone furthest, with 75 descendants of its own.

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—

More from Scimed Life Systems, Inc.

358 FDA decisions under this applicant name. See the company

  • P860019/S264Apex Monorail & Apex Otw Ptca Dilatation Catheter/MAVERICK2 Monorail Ptca Catheter/Maverick Otw Ptca…Scimed Life Systems, Inc. · 2011
  • P860019/S263Apex Ptca & NC Quantum Apex Ptca CathetersScimed Life Systems, Inc. · 2010
  • P860019/S261MAVERICK2 Monorail Ptca Dilatation CatheterScimed Life Systems, Inc. · 2010
  • P860019/S260Ptca Catheters (MAVERICK2/Maverick/Maverick XL/Quantum/Maverick/Apex)Scimed Life Systems, Inc. · 2010
  • P860019/S259Ptca CathetersScimed Life Systems, Inc. · 2010

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/K932616 · printed Nov 6, 2026

Cite this page

510(k) Report. “K932616: Scimed (R) Dispatch (TM) Coronary Infusion Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K932616

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026