510(k) · Cleared
ClearedSUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cordis Corporation · DQO Catheter, Intravascular, Diagnostic
Cleared on Feb 17, 2022 as substantially equivalent to K992347 (Cordis Corp., 1999) after a 153-day review. Its family tree reaches back 1 generation to 1999. 1 of the 2 devices in its family, counting itself, has a Class I recall.
- Decided
- Feb 17, 2022
- Review
- 153 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K992347 (1999). No later device cites it as a predicate yet. 1 of the 2 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK992347 Cordis Super Torque MB Angiographic Catheter with Radiopaque Marker…Cordis Corp. · 1999 · Recalled (Class I)
- This deviceK212977 SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbandsCordis Corporation · 2022
Class I recalls in this family
- K992347 Cordis Super Torque MB Angiographic Catheter…direct predicate · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992347 | Cordis Super Torque MB Angiographic Catheter with Radiopaque Marker Bands | Cordis Corp. | 1999 | Class I |
| 0 (this device) | K212977 | SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands | Cordis Corporation | 2022 | — |
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 |
|---|---|---|---|
| * | K992347 | Cordis Super Torque MB Angiographic Catheter with Radiopaque Marker BandsSummary page 4…(21 CFR 870.1200), Class II Product Code: DQO III. PREDICATE DEVICE SUPER TORQUE® MB Angiographic Catheter with Radiopaque Marker Bands cleared on October 8, 1999 under K992347. IV. DEVICE DESCRIPTION The SUPER TORQUE® MB Angiographic Catheter is a thin plastic tube which is inserted into an artery thr… | 1999 |
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.
- K992347Cordis Super Torque MB Angiographic Catheter with Radiopaque Marker BandsCordis Corp. · 1999 · Direct predicate · ◆ on the line of descent in FIG. 15 Class I recalls
What does this lineage say?
- Its one ancestor has a recall, Class I.
- 1 other device also cites its predicate K992347.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
Cordis Angiographic Catheters with Marker Bands are designed to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to selected sites in the vascular system.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K212977 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212977: SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212977
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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