510(k) · Cleared
ClearedImpress Angiographic Catheter with Hydrophilic Coating
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merit Medical Systems, Inc. · DQO Catheter, Intravascular, Diagnostic
Cleared on Feb 12, 2010 as substantially equivalent to K053171 (Merit Medical Systems, Inc., 2006) and 1 other predicate after a 137-day review. Its family tree reaches back 2 generations to 2000. 1 of the 9 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.
- Decided
- Feb 12, 2010
- Review
- 137 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K000659 (2000). 4 ancestors in all, the oldest K915414 (1992). 4 later devices descend from it, 2 citing it directly. 1 of the 9 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK000659 Modification to Softouch Diagnostic Intravascular CatMerit Medical Systems, Inc. · 2000 · Recalled
- 1 generation backK053171 Merit Impress Diagnostic CatheterMerit Medical Systems, Inc. · 2006
- This deviceK093004 Impress Angiographic Catheter with Hydrophilic CoatingMerit Medical Systems, Inc. · 2010
- Descendant · cites it directly · 2 of its ownK191608 Impress Angiographic CatheterMerit Medical Systems, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK233268 Impress Angiographic CatheterMerit Medical Systems, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK233975 Zoom 6F Insert CathetersImperative Care, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK130378 Respiguide Delivery SystemRespicardia · 2013
Class I recalls in this family
- K001578 Angiodynamics Soft-VU Hydrophilic Coated…2 generations back · 2000
Most influential descendants
Showing 4 of 4 · See all- K191608Impress Angiographic CatheterMerit Medical Systems, Inc. · 2019 · cites it directly2descendants
- K233268Impress Angiographic CatheterMerit Medical Systems, Inc. · 2024 · 2 generations on0descendants
- K233975Zoom 6F Insert CathetersImperative Care, Inc. · 2024 · 2 generations on0descendants
- K130378Respiguide Delivery SystemRespicardia · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000659 | Modification to Softouch Diagnostic Intravascular Cat | Merit Medical Systems, Inc. | 2000 | 1 |
| −1 | K053171 | Merit Impress Diagnostic Catheter | Merit Medical Systems, Inc. | 2006 | — |
| 0 (this device) | K093004 | Impress Angiographic Catheter with Hydrophilic Coating | Merit Medical Systems, Inc. | 2010 | — |
| +1 | K191608 | Impress Angiographic Catheter | Merit Medical Systems, Inc. | 2019 | — |
| +2 | K233268 | Impress Angiographic Catheter | Merit Medical Systems, Inc. | 2024 | — |
| +2 | K233975 | Zoom 6F Insert Catheters | Imperative Care, Inc. | 2024 | — |
| +1 | K130378 | Respiguide Delivery System | Respicardia | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2000 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 2 | 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.
1 device in this family has 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 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? (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 |
|---|---|---|---|
| * | K053171 | Merit Impress Diagnostic CatheterSummary page 1…Trade Name: Impress® Angiographic Catheter Predicate Classification Name: Diagnostic Intravascular Catheter Device Premarket Notification: K053171 Manufacturer: Merit Medical Systems, Inc. Trade Name: Radifocus® Glidec… | 2006 |
| * | K915414 | Terumo Angiogtaphic CatheterSummary page 1…Trade Name: Radifocus® Glidecath~ Predicate Classification Name: Diagnostic Intravascular Catheter Device Premarket Notification: K915414 Manufacturer: Terumo Corporation Class 11 Classification 21 CFR § 870.1200, 74 DQ… | 1992 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 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.
- K001578Angiodynamics Soft-VU Hydrophilic Coated Angiographic CatheterAngioDynamics, Inc. · 2000 · 2 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 10 years and passes through 1 company; a new generation was cleared every 5.8 years on median.
- 2 of the 4 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K191608 (Merit Medical Systems, Inc., 2019) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K053171.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
Angiography catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures. Angiographic catheters with marker bands may also be used for anatomical measurements.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093004 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093004: Impress Angiographic Catheter with Hydrophilic Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093004
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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