510(k) Report

510(k) · Cleared

Cleared

Ces Masstransit Infusion Catheter

K974222510(k) TraditionalCleared Feb 10, 199890-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

Cordis Neurovascular, Inc. · KRA Catheter, Continuous Flush

Cleared on Feb 10, 1998 as substantially equivalent to K952874 (Cordis Neurovascular, Inc., 1995) and 5 other predicates after a 90-day review. Its family tree reaches back 2 generations to 1995.

Decided
Feb 10, 1998
Review
90 days
Class
Class II
Product code
KRA
Recalls
None
Predicates
8

Its longest line of descent runs back 2 generations to K945904 (1995). 8 ancestors in all, the oldest K936260 (1994). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1997: 1 other ancestor1996: 1 other ancestor1995: 2 other ancestors1994: 2 other ancestorsK945904 · Scimed (R) Venture (TM) II Infusion Catheter · Scimed Peripheral Interventions · 1995K972518 · Transit/Rapidtransit/Speedster/Prowler Infusion Catheter · Cordis Neurovascular, Inc. · 1997199019921994199619982000
Other ancestors, by generation 1 generation back: 5 other ancestors2 generations back: 1 other ancestor K972518 · Transit/Rapidtransit/Speedster/Prowler Infusion Catheter · Cordis Neurovascular, Inc. · 1997K945904 · Scimed (R) Venture (TM) II Infusion Catheter · Scimed Peripheral Interventions · 19950
  1. Root · 2 generations backK945904 Scimed (R) Venture (TM) II Infusion CatheterScimed Peripheral Interventions · 1995
  2. 1 generation backK972518 Transit/Rapidtransit/Speedster/Prowler Infusion CatheterCordis Neurovascular, Inc. · 1997
  3. This deviceK974222 Ces Masstransit Infusion CatheterCordis Neurovascular, Inc. · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K945904Scimed (R) Venture (TM) II Infusion CatheterScimed Peripheral Interventions1995—
−1K972518Transit/Rapidtransit/Speedster/Prowler Infusion CatheterCordis Neurovascular, Inc.1997—
0 (this device)K974222Ces Masstransit Infusion CatheterCordis Neurovascular, Inc.1998—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199420
199520
199610
199710
FIG. 1 — Lineage of K974222, 1995–1998Source: 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
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What was it cleared against? (9)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K952874Transit Infusion Catheter
Summary page 2
…Provisions e CES MassTRANSIT Infusion Catheter Predicate The predicate devices are listed in the table below. Devices CES TRANSIT Cordis Endovascular Systems, Inc. | K952874, K936260 DQO K936282, K965181, KRA K972518 FasTRACKER ® 325 | Target Therapeutics K960806* DQO* K953900, K953892* DQO JETSTREAM…
Cordis Neurovascular, Inc.1995—
*K936260Transit Infusion Catheter
Summary page 2
…ns e CES MassTRANSIT Infusion Catheter Predicate The predicate devices are listed in the table below. Devices CES TRANSIT Cordis Endovascular Systems, Inc. | K952874, K936260 DQO K936282, K965181, KRA K972518 FasTRACKER ® 325 | Target Therapeutics K960806* DQO* K953900, K953892* DQO JETSTREAM® 327 Med…
Cordis Corp.1994—
*K936282Transit Infusion Catheter (Neurovascular Use)
Summary page 2
…sTRANSIT Infusion Catheter Predicate The predicate devices are listed in the table below. Devices CES TRANSIT Cordis Endovascular Systems, Inc. | K952874, K936260 DQO K936282, K965181, KRA K972518 FasTRACKER ® 325 | Target Therapeutics K960806* DQO* K953900, K953892* DQO JETSTREAM® 327 Medtronic KRA…
Cordis Neurovascular, Inc.1994—
*K965181Ces Infusion Catheter
Summary page 2
…Infusion Catheter Predicate The predicate devices are listed in the table below. Devices CES TRANSIT Cordis Endovascular Systems, Inc. | K952874, K936260 DQO K936282, K965181, KRA K972518 FasTRACKER ® 325 | Target Therapeutics K960806* DQO* K953900, K953892* DQO JETSTREAM® 327 Medtronic KRA * This in…
Cordis Neurovascular, Inc.1997—
*K972518Transit/Rapidtransit/Speedster/Prowler Infusion Catheter
Summary page 2
…eter Predicate The predicate devices are listed in the table below. Devices CES TRANSIT Cordis Endovascular Systems, Inc. | K952874, K936260 DQO K936282, K965181, KRA K972518 FasTRACKER ® 325 | Target Therapeutics K960806* DQO* K953900, K953892* DQO JETSTREAM® 327 Medtronic KRA * This information Is…
Cordis Neurovascular, Inc.1997—
*K960806Turbo Tracker
Summary page 2
…in the table below. Devices CES TRANSIT Cordis Endovascular Systems, Inc. | K952874, K936260 DQO K936282, K965181, KRA K972518 FasTRACKER ® 325 | Target Therapeutics K960806* DQO* K953900, K953892* DQO JETSTREAM® 327 Medtronic KRA * This information Is assumed based on our best current knowledge. Cl…
Target Therapeutics1996—
Kept off the family treeK953900FasTRACKER 325
Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree
Summary page 2
…below. Devices CES TRANSIT Cordis Endovascular Systems, Inc. | K952874, K936260 DQO K936282, K965181, KRA K972518 FasTRACKER ® 325 | Target Therapeutics K960806* DQO* K953900, K953892* DQO JETSTREAM® 327 Medtronic KRA * This information Is assumed based on our best current knowledge. Classification C…
Kept off the family treeK953892FasTRACKER 325
Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree
Summary page 2
…evices CES TRANSIT Cordis Endovascular Systems, Inc. | K952874, K936260 DQO K936282, K965181, KRA K972518 FasTRACKER ® 325 | Target Therapeutics K960806* DQO* K953900, K953892* DQO JETSTREAM® 327 Medtronic KRA * This information Is assumed based on our best current knowledge. Classification Class Il…
*—Jetstream 327
Named without a submission number
—

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 3 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
  • None of the 8 ancestors has a recall.

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?

CES MassTRANSIT Infusion Catheters are indicated for the selective infusion of various diagnostic, therapeutic and embolic agents into the peripheral, coronary and neurovasculatures.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Cordis Neurovascular, Inc.

37 FDA decisions under this applicant name. See the company

  • K082324Trufill DCS SyringeCordis Neurovascular, Inc. · 2008
  • K080967Trufill DCS Orbit Detachable Coil and Trufill DCS Syringe or Trufill DCS Syringe II, Also Known as the…Cordis Neurovascular, Inc. · 2008
  • K071962Vascular Occlusion System (Trufill Pushable Coils and Trupush Coil Pusher)Cordis Neurovascular, Inc. · 2007
  • K070279Modification to Hypertransit Infusion CatheterCordis Neurovascular, Inc. · 2007
  • K063254The Trufill DCS Detachable Coil System; the Trufill DCS Orbit Detachable Coil SystemCordis Neurovascular, Inc. · 2006

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/K974222 · printed Nov 4, 2026

Cite this page

510(k) Report. “K974222: Ces Masstransit 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/K974222

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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