510(k) · Cleared
ClearedProgreat
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Medical Corp. · KRA Catheter, Continuous Flush
Cleared on Mar 11, 2004 as substantially equivalent to K033583 (Terumo Medical Corp., 2003) and 1 other predicate after an 85-day review. Its family tree reaches back 5 generations to 1996. 3 later devices descend from it.
- Decided
- Mar 11, 2004
- Review
- 85 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K961923 (1996). 11 ancestors in all, the oldest K871047 (1987). 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK961923 Berenstein CoilTarget Therapeutics · 1996
- 4 generations backK964112 Berenstein CoilTarget Therapeutics · 1997
- 3 generations backK991549 Embosphere MicrospheresBiosphere Medical · 2000
- 2 generations backK021397 Embosphere Microspheres and Embogold Microspheres for Use in Uterine…Biosphere Medical, Inc. · 2002
- 1 generation backK030966 Contour Emboli Pva and Fastracker-325 Infusion CatheterBoston Scientific Corp · 2003 · Recalled
- This deviceK033913 ProgreatTerumo Medical Corp. · 2004
- Descendant · cites it directly · 1 of its ownK171665 Microcatheter and guide-wire systemSuzhou Hengrui Disheng Medical Co., Ltd. · 2018
- Descendant · 2 generations on · 0 of its ownK212719 Micro Catheter and Guidewire SystemSuzhou Hengrui Hongyuan Medical Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK161967 FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cmCallisyn Biomedical, Inc. · 2017
Most influential descendants
Showing 3 of 3 · See all- K171665Microcatheter and guide-wire systemSuzhou Hengrui Disheng Medical Co., Ltd. · 2018 · cites it directly1descendant
- K212719Micro Catheter and Guidewire SystemSuzhou Hengrui Hongyuan Medical Co., Ltd. · 2022 · 2 generations on0descendants
- K161967FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cmCallisyn Biomedical, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K961923 | Berenstein Coil | Target Therapeutics | 1996 | — |
| −4 | K964112 | Berenstein Coil | Target Therapeutics | 1997 | — |
| −3 | K991549 | Embosphere Microspheres | Biosphere Medical | 2000 | — |
| −2 | K021397 | Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid… | Biosphere Medical, Inc. | 2002 | — |
| −1 | K030966 | Contour Emboli Pva and Fastracker-325 Infusion Catheter | Boston Scientific Corp | 2003 | 1 |
| 0 (this device) | K033913 | Progreat | Terumo Medical Corp. | 2004 | — |
| +1 | K171665 | Microcatheter and guide-wire system | Suzhou Hengrui Disheng Medical Co., Ltd. | 2018 | — |
| +2 | K212719 | Micro Catheter and Guidewire System | Suzhou Hengrui Hongyuan Medical Co., Ltd. | 2022 | — |
| +1 | K161967 | FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm | Callisyn Biomedical, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 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 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 K253509 TriSalus TriNav Advance Infusion Systemscore 14.4 · 9 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 |
|---|---|---|---|
| * | K033583 | ProgreatSummary page 2…ssories included in this 510(k) are operated manually or by a manual process. E. Design /Materials This device is the identical device cleared under K033583. There are no material or design changes therefore there are no new issues of safety and effectiveness.… | 2003 |
| * | K030966 | Contour Emboli Pva and Fastracker-325 Infusion CatheterSummary page 4…alent in intended use and design, technology/principles of operation to the Boston Scientific Corporation Fas- Tracker-325® Infusion Catheter cleared under K030966. Differences between the devices do not raise any significant issues of safety or effectiveness. J. Submitter Informa… | 2003 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 8 years and passes through 5 companies; a new generation was cleared every 10 months on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K171665 (Suzhou Hengrui Disheng Medical Co., Ltd., 2018) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K033583.
How does its category compare?
All KRA devicesKRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KRA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KRA
63in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRA
41so far in 2026, the most since 2007
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · KRA
980in 2025
MAUDE reports naming product code KRA, 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 | 44 | 2 | 118 |
| 2008 | 7 | 144 | 6 | 117 |
| 2009 | 5 | 69 | 8 | 187 |
| 2010 | 2 | — | 26 | 355 |
| 2011 | 2 | — | 3 | 239 |
| 2012 | 3 | 29 | 3 | 217 |
| 2013 | 3 | 126 | 2 | 209 |
| 2014 | 4 | 61 | 3 (2) | 276 |
| 2015 | 0 | — | 1 | 339 |
| 2016 | 8 | 122 | 3 (1) | 418 |
| 2017 | 4 | 166 | 0 | 538 |
| 2018 | 4 | 178 | 0 | 434 |
| 2019 | 4 | 133 | 4 (4) | 418 |
| 2020 | 6 | 29 | 1 | 381 |
| 2021 | 6 | 108 | 0 | 440 |
| 2022 | 6 | 228 | 0 | 543 |
| 2023 | 7 | 63 | 2 | 829 |
| 2024 | 0 | — | 0 | 942 |
| 2025 | 1 | — | 0 | 980 |
| 2026 | 5 | 268 | 41 | — |
What is it indicated for?
The ProgreatTM is intended for the infusion of contrast media into all peripheral vessels up to and including the cervical vessels, all vessels in the lower and upper extremities, visceral vessels, and all coronary vessels. The Progreat is also intended for drug infusion in intra-arterial therapy and the infusion of embolic materials for hemostasis in procedures including but not limited to Uterine Fibroid Embolization. The Progreat should not be used in cerebral vessels.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033913 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033913: Progreat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033913
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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