510(k) · Cleared
ClearedZoom 6F Insert Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imperative Care, Inc. · DQO Catheter, Intravascular, Diagnostic
Cleared on Apr 2, 2024 as substantially equivalent to K191608 (Merit Medical Systems, Inc., 2019) after a 109-day review. Its family tree reaches back 4 generations to 2000. 1 of the 7 devices in its family, counting itself, has a Class I recall.
- Decided
- Apr 2, 2024
- Review
- 109 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K000659 (2000). 6 ancestors in all, the oldest K915414 (1992). No later device cites it as a predicate yet. 1 of the 7 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK000659 Modification to Softouch Diagnostic Intravascular CatMerit Medical Systems, Inc. · 2000 · Recalled
- 3 generations backK053171 Merit Impress Diagnostic CatheterMerit Medical Systems, Inc. · 2006
- 2 generations backK093004 Impress Angiographic Catheter with Hydrophilic CoatingMerit Medical Systems, Inc. · 2010
- 1 generation backK191608 Impress Angiographic CatheterMerit Medical Systems, Inc. · 2019
- This deviceK233975 Zoom 6F Insert CathetersImperative Care, Inc. · 2024
Class I recalls in this family
- K001578 Angiodynamics Soft-VU Hydrophilic Coated…4 generations back · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000659 | Modification to Softouch Diagnostic Intravascular Cat | Merit Medical Systems, Inc. | 2000 | 1 |
| −3 | K053171 | Merit Impress Diagnostic Catheter | Merit Medical Systems, Inc. | 2006 | — |
| −2 | K093004 | Impress Angiographic Catheter with Hydrophilic Coating | Merit Medical Systems, Inc. | 2010 | — |
| −1 | K191608 | Impress Angiographic Catheter | Merit Medical Systems, Inc. | 2019 | — |
| 0 (this device) | K233975 | Zoom 6F Insert Catheters | Imperative Care, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2000 | 1 | 1 |
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? (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 |
|---|---|---|---|
| * | K191608 | Impress Angiographic CatheterSummary page 4…gulation: 21 CFR. 870.1200 Manufacturer: Merit Medical Systems, Inc. 510(k) #'s: K191608 D. Device Description: The Imperative Care Zoom™ 6F Insert Catheters are single lumen, braid reinforced, variable stif… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 4 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 24 years and passes through 2 companies; a new generation was cleared every 5.8 years on median.
- 2 of the 6 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K191608.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Zoom 6F Insert Catheters are indicated for use in delivering radiopaque media to selected sites in the peripheral vascular system in conjunction with routine diagnostic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233975 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233975: Zoom 6F Insert Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233975
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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