510(k) · Cleared
ClearedProgreat
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Medical Corp. · DQO Catheter, Intravascular, Diagnostic
Cleared on Dec 12, 2003 as substantially equivalent to K981359 (Terumo Medical Corp., 1999) after a 29-day review. Its family tree reaches back 2 generations to 1992. 13 later devices descend from it.
- Decided
- Dec 12, 2003
- Review
- 29 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K915414 (1992). 13 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK915414 Terumo Angiogtaphic CatheterTerumo Medical Corp. · 1992
- 1 generation backK981359 GT LeggieroTerumo Medical Corp. · 1999
- This deviceK033583 ProgreatTerumo Medical Corp. · 2003
- Descendant · cites it directly · 3 of its ownK173430 SeQure® NF and SeQure® MicrocathetersAccurate Medical Therapeutics, Ltd. · 2018
- Descendant · cites it directly · 3 of its ownK033913 ProgreatTerumo Medical Corp. · 2004
- Descendant · 2 generations on · 2 of its ownK202797 Drakon and Sequre MicrocathetersAccurate Medical Therapeutics, Ltd. · 2020
- Descendant · 2 generations on · 1 of its ownK203487 Drakon and Sequre MicrocathetersAccurate Medical Therapeutics, Ltd. · 2020
- Descendant · 2 generations on · 1 of its ownK171665 Microcatheter and guide-wire systemSuzhou Hengrui Disheng Medical Co., Ltd. · 2018
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K173430SeQure® NF and SeQure® MicrocathetersAccurate Medical Therapeutics, Ltd. · 2018 · cites it directly3descendants
- K033913ProgreatTerumo Medical Corp. · 2004 · cites it directly3descendants
- K202797Drakon and Sequre MicrocathetersAccurate Medical Therapeutics, Ltd. · 2020 · 2 generations on2descendants
- K203487Drakon and Sequre MicrocathetersAccurate Medical Therapeutics, Ltd. · 2020 · 2 generations on1descendant
- K171665Microcatheter and guide-wire systemSuzhou Hengrui Disheng Medical Co., Ltd. · 2018 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K915414 | Terumo Angiogtaphic Catheter | Terumo Medical Corp. | 1992 | — |
| −1 | K981359 | GT Leggiero | Terumo Medical Corp. | 1999 | — |
| 0 (this device) | K033583 | Progreat | Terumo Medical Corp. | 2003 | — |
| +1 | K173430 | SeQure® NF and SeQure® Microcatheters | Accurate Medical Therapeutics, Ltd. | 2018 | — |
| +1 | K033913 | Progreat | Terumo Medical Corp. | 2004 | — |
| +2 | K202797 | Drakon and Sequre Microcatheters | Accurate Medical Therapeutics, Ltd. | 2020 | — |
| +2 | K203487 | Drakon and Sequre Microcatheters | Accurate Medical Therapeutics, Ltd. | 2020 | — |
| +2 | K171665 | Microcatheter and guide-wire system | Suzhou Hengrui Disheng Medical Co., Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 DQO? 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 DQO device
- #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K981359 | GT LeggieroSummary page 1…materials for hemostasis. The Catheter should not be used in cerebral vessels. Note: This is the same intended use as the predicate device - GT LEGGIERO K981359. C. Device Description The PROGREAT catheter is available with or without the following accessories: guide… | 1999 |
| † | K771205 | Hypodermic Syringe | 1977 |
| † | K915414 | Terumo Angiogtaphic Catheter | 1992 |
What descends from it? (13)
See all 136 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 11 years and passes through 1 company; a new generation was cleared every 7.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K173430 (Accurate Medical Therapeutics, Ltd., 2018) has gone furthest, with 3 descendants of its own.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQO
148in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQO
1in 2023
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · DQO
656in 2025
MAUDE reports naming product code DQO, 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 | 8 | 106 | 14 | 564 |
| 2008 | 3 | 80 | 4 | 726 |
| 2009 | 8 | 58 | 7 | 933 |
| 2010 | 7 | 137 | 11 | 556 |
| 2011 | 6 | 74 | 7 | 625 |
| 2012 | 15 | 94 | 2 | 532 |
| 2013 | 2 | — | 1 | 753 |
| 2014 | 3 | 109 | 0 | 601 |
| 2015 | 10 | 209 | 1 (1) | 628 |
| 2016 | 4 | 89 | 2 (1) | 614 |
| 2017 | 10 | 176 | 1 | 873 |
| 2018 | 10 | 234 | 2 | 777 |
| 2019 | 6 | 113 | 71 | 386 |
| 2020 | 3 | 30 | 4 (4) | 312 |
| 2021 | 1 | — | 0 | 338 |
| 2022 | 4 | 181 | 1 | 379 |
| 2023 | 4 | 73 | 1 (1) | 391 |
| 2024 | 4 | 148 | 0 | 511 |
| 2025 | 2 | — | 0 | 656 |
| 2026 | 3 | 85 | 24 (4) | — |
What is it indicated for?
The PROGREAT Catheter 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 and all coronary vessels. The PROGREAT Catheter is also intended for drug infusion in intra-arterial therapy and the infusion of embolic materials for hemostasis. The Catheter should not be used in cerebral vessels.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033583 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033583: Progreat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033583
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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