510(k) · Cleared
Recalled · Class I · 2026Imager 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 14, 2012 as substantially equivalent to K011664 (Boston Scientific/Medi-Tech, 2001) and 1 other predicate after a 99-day review. Its family tree reaches back 1 generation to 2001. 2 of the 5 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled 4 times, including 2 Class I recalls.
- Decided
- Sep 14, 2012
- Review
- 99 days
- Class
- Class II
- Product code
- DQO
- Recalls
- 4 (2 Class I)
- Predicates
- 2
Its longest line of descent runs back 1 generation to K011664 (2001). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly. 2 of the 5 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK011664 Imager II Angiographic CatheterBoston Scientific/Medi-Tech · 2001 · Recalled
- This deviceK121694 Imager II Angiographic CatheterBoston Scientific Corp · 2012
- Descendant · cites it directly · 1 of its ownK133130 Beacon Tip Torcon NB Advantage Catheter, Torcon NB Advantage CatheterCook, Inc. · 2015 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK161822 Torcon NB Advantage CathetersCook Incorporated · 2016
Class I recalls in this family
- K133130 Beacon Tip Torcon NB Advantage Catheter, Torcon…cites it directly · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011664 | Imager II Angiographic Catheter | Boston Scientific/Medi-Tech | 2001 | 2 |
| 0 (this device) | K121694 | Imager II Angiographic Catheter | Boston Scientific Corp | 2012 | — |
| +1 | K133130 | Beacon Tip Torcon NB Advantage Catheter, Torcon NB Advantage Catheter | Cook, Inc. | 2015 | Class I |
| +2 | K161822 | Torcon NB Advantage Catheters | Cook Incorporated | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 1 |
| 2016 | 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.
2 devices in this family have 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 |
|---|---|---|---|
| * | K011664 | Imager II Angiographic CatheterSummary page 1…Diagnostic Intravascular Catheter Classification: 11 Product Code: 000/ 21 CFR 870.1200 Predicate Device: Imager TM 11 Angiographic Catheter (K01 1664, September 07, 2001) and Renegade STO 18 Microcatheter (K023681 November 26, 2002). Device Description: The 5F Selective Imager 1… | 2001 |
| * | K023681 | Renegade STC 18 MicrocatheterSummary page 1…oduct Code: 000/ 21 CFR 870.1200 Predicate Device: Imager TM 11 Angiographic Catheter (K01 1664, September 07, 2001) and Renegade STO 18 Microcatheter (K023681 November 26, 2002). Device Description: The 5F Selective Imager 11Angiographic catheters without sideholes are sterile, single us… | 2002 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133130 | Beacon Tip Torcon NB Advantage Catheter, Torcon NB Advantage Catheter Class I | 2015 | 1 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 24, 2026 | Class I | Z-3214-2026 | Process control | Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged procedure or life-threatening embolism. |
| Feb 11, 2020 | Class I | Z-1555-2020 | Environmental control | Potential for tip detachment of Imager II 5F Angiographic Catheters |
| Dec 15, 2016 | Class II | Z-2645-2017 | Employee error | A field report indicated some units within this lot were missing the bottom pouch seal. The compromised seal is completely missing and is obvious to the user. |
| Dec 13, 2016 | Class II | Z-1781-2017 | Employee error | One lot of Imager II Angiographic Catheters is being recalled due to packaging mislabeling. The product may be labeled as Imager II Contra 2 curve catheters, when in fact the package contains Contra curve catheters. |
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.
- K133130Beacon Tip Torcon NB Advantage Catheter, Torcon NB Advantage CatheterCook, Inc. · 2015 · Cites it directly · ◆ in the 2015 descendants 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. 2012, 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 Imager 11Angiographic Catheters are designed to provide a pathway for delivering contrast media to selected sites in the vascular system including the carotid arteries.
Additionally, the 5F Seleactive Imager 11Arigiographic Catheters without sideholes can be used for the controlled and selective delivery of the Boston Scientific lnterlockTh-35 Detachable Coils into the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121694 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121694: 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/K121694
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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