510(k) · Cleared
ClearedMerit Impress Diagnostic Catheter
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 Jan 19, 2006 as substantially equivalent to K000659 (Merit Medical Systems, Inc., 2000) and 1 other predicate after a 66-day review. Its family tree reaches back 1 generation to 2000. 1 of the 13 devices in its family, counting itself, has a Class I recall. 10 later devices descend from it.
- Decided
- Jan 19, 2006
- Review
- 66 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K000659 (2000). 2 ancestors in all. 10 later devices descend from it, 5 citing it directly. 1 of the 13 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK000659 Modification to Softouch Diagnostic Intravascular CatMerit Medical Systems, Inc. · 2000 · Recalled
- This deviceK053171 Merit Impress Diagnostic CatheterMerit Medical Systems, Inc. · 2006
- Descendant · cites it directly · 4 of its ownK093004 Impress Angiographic Catheter with Hydrophilic CoatingMerit Medical Systems, Inc. · 2010
- Descendant · cites it directly · 3 of its ownK120158 Coronary Sinus Guide and Lateral Vein Introducer KitsThomas Medical Products, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 2 of its ownK191608 Impress Angiographic CatheterMerit Medical Systems, Inc. · 2019
- Descendant · 2 generations on · 1 of its ownK152116 5.5 F Worley Advanced LVI Lateral Vein IntroducerMerit Medical Systems, Inc. · 2015
- Descendant · 3 generations on · 0 of its ownK260459 VANES Delivery System (VDS)Zoll Respicardia, Inc. · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K001578 Angiodynamics Soft-VU Hydrophilic Coated…direct predicate · 2000
Most influential descendants
Showing 5 of 10 · See all- K093004Impress Angiographic Catheter with Hydrophilic CoatingMerit Medical Systems, Inc. · 2010 · cites it directly4descendants
- K120158Coronary Sinus Guide and Lateral Vein Introducer KitsThomas Medical Products, Inc. · 2012 · cites it directly3descendants
- K191608Impress Angiographic CatheterMerit Medical Systems, Inc. · 2019 · 2 generations on2descendants
- K1521165.5 F Worley Advanced LVI Lateral Vein IntroducerMerit Medical Systems, Inc. · 2015 · 2 generations on1descendant
- K260459VANES Delivery System (VDS)Zoll Respicardia, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000659 | Modification to Softouch Diagnostic Intravascular Cat | Merit Medical Systems, Inc. | 2000 | 1 |
| 0 (this device) | K053171 | Merit Impress Diagnostic Catheter | Merit Medical Systems, Inc. | 2006 | — |
| +1 | K093004 | Impress Angiographic Catheter with Hydrophilic Coating | Merit Medical Systems, Inc. | 2010 | — |
| +1 | K120158 | Coronary Sinus Guide and Lateral Vein Introducer Kits | Thomas Medical Products, Inc. | 2012 | 2 |
| +2 | K191608 | Impress Angiographic Catheter | Merit Medical Systems, Inc. | 2019 | — |
| +2 | K152116 | 5.5 F Worley Advanced LVI Lateral Vein Introducer | Merit Medical Systems, Inc. | 2015 | — |
| +3 | K260459 | VANES Delivery System (VDS) | Zoll Respicardia, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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.
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 |
|---|---|---|---|
| * | K000659 | Modification to Softouch Diagnostic Intravascular CatSummary page 1…Classification Panel Number 870 Cardiovascular Devices Product Code DOQ Clearance Status K000659 Merit Medical Systems, Inc. Merit ImpressTM Radiology Catheter… | 2000 |
| * | K001578 | Angiodynamics Soft-VU Hydrophilic Coated Angiographic CatheterSummary page 2…ion Panel Number 870 Cardiovascular Product Code DQO Clearance Status K001578 Manufacturer AngioDynamics Inc. Registration Number… | 2000 |
What descends from it? (10)
5 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 · Direct predicate · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
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?
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/K053171 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053171: Merit Impress Diagnostic Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053171
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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