510(k) · Cleared
ClearedProgreat
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ashitaka Factory of Terumo Corporation · DQO Catheter, Intravascular, Diagnostic
Cleared on Jul 21, 2017 as substantially equivalent to K033583 (Terumo Medical Corp., 2003) after a 177-day review. Its family tree reaches back 3 generations to 1992. 1 later device descends from it.
- Decided
- Jul 21, 2017
- Review
- 177 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K915414 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK915414 Terumo Angiogtaphic CatheterTerumo Medical Corp. · 1992
- 2 generations backK981359 GT LeggieroTerumo Medical Corp. · 1999
- 1 generation backK033583 ProgreatTerumo Medical Corp. · 2003
- This deviceK170223 ProgreatAshitaka Factory of Terumo Corporation · 2017
- Descendant · cites it directly · 0 of its ownK232536 Soldier MicrocatheterEmbolx, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K232536Soldier MicrocatheterEmbolx, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K915414 | Terumo Angiogtaphic Catheter | Terumo Medical Corp. | 1992 | — |
| −2 | K981359 | GT Leggiero | Terumo Medical Corp. | 1999 | — |
| −1 | K033583 | Progreat | Terumo Medical Corp. | 2003 | — |
| 0 (this device) | K170223 | Progreat | Ashitaka Factory of Terumo Corporation | 2017 | — |
| +1 | K232536 | Soldier Microcatheter | Embolx, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K033583 | ProgreatSummary page 6…r Product Code: DQO C. PREDICATE DEVICE (807.92(A)(3)) The legally marketed device(s) to which substantial equivalence is claimed: K033583, Terumo Progreat, manufactured by Ashitaka Factory of Terumo Corporation D. REASON FOR 510(K) SUBMISSION This… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232536 | Soldier Microcatheter | 2024 | 0 |
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 25 years and passes through 2 companies; a new generation was cleared every 7.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K232536 (Embolx, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K033583.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
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 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 is also intended for drug infusion in intra-arterial therapy and the infusion of embolic materials for hemostasis. The Progreat should not be used in cerebral vessels.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170223 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170223: Progreat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170223
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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