510(k) · Cleared
Recalled · 2012Imager II Angiographic Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · DQO Catheter, Intravascular, Diagnostic
Cleared on Sep 2, 2005 as substantially equivalent to K011664 (Boston Scientific/Medi-Tech, 2001) and 1 other predicate after a 150-day review. Its family tree reaches back 2 generations to 2001. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Sep 2, 2005
- Review
- 150 days
- Class
- Class II
- Product code
- DQO
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 2 generations to K011664 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK011664 Imager II Angiographic CatheterBoston Scientific/Medi-Tech · 2001 · Recalled
- 1 generation backK022621 Boston Scientific Imager II 4F Selective Angiographic CatheterBoston Scientific Corp · 2002 · Recalled
- This deviceK050863 Imager II Angiographic CatheterBoston Scientific Corp · 2005
- Descendant · cites it directly · 0 of its ownK120893 Imager II Angiographic CathetersBoston Scientific Corp · 2012
Most influential descendants
Showing 1 of 1 · See all- K120893Imager II Angiographic CathetersBoston Scientific Corp · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011664 | Imager II Angiographic Catheter | Boston Scientific/Medi-Tech | 2001 | 2 |
| −1 | K022621 | Boston Scientific Imager II 4F Selective Angiographic Catheter | Boston Scientific Corp | 2002 | 1 |
| 0 (this device) | K050863 | Imager II Angiographic Catheter | Boston Scientific Corp | 2005 | — |
| +1 | K120893 | Imager II Angiographic Catheters | Boston Scientific Corp | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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? (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 |
|---|---|---|---|
| * | K011664 | Imager II Angiographic CatheterSummary page 1…oduct Code DQO Classification of Class II, 21 CFR Part 870.1200 Device Predicate Device Imager T M IIAngiographic K011664 9/07/2001 Catheter K022621 9/04/2002 The Ima… | 2001 |
| * | K022621 | Boston Scientific Imager II 4F Selective Angiographic CatheterSummary page 1…edicate Device Imager T M IIAngiographic K011664 9/07/2001 Catheter K022621 9/04/2002 The Imager IIAngiographic Catheters are sterile, single-use Device diagnostic… | 2002 |
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 |
|---|---|---|---|
| K120893 | Imager II Angiographic Catheters | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 15, 2012 | Not classified | Z-1394-2012 | Package design/selection | Boston Scientific Corporation is initiating a Medical Device Recall of certain lots/batches of the Imager" II Catheter (Urology) and the Imager" II Angiographic Catheter . An investigation has found that, during shipping, some units in… |
| Oct 22, 2009 | Not classified | Z-0336-2010 | Packaging process control | The sterile barrier in the packaging (pouch) that contains the catheter may be breached. The breach of sterility could lead to a contamination of the device with subsequent transfer of infectious agents to the patient. |
| Oct 12, 2007 | Not classified | Z-0279-2008 | Packaging | Mislabeled: Units within the identified lot/batch were incorrectly labeled as 5F on the outer carton and pouch when the product was actually a 4F device. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K120893 (Boston Scientific Corp, 2012) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K011664.
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 Imager II Angiographic Catheters are designed to provide a pathway for delivering contrast media to selected sites in the vascular system including the carotid arteries
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050863 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050863: Imager II Angiographic Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050863
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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