510(k) · Cleared
ClearedTorcon NB Advantage Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · DQO Catheter, Intravascular, Diagnostic
Cleared on Oct 27, 2016 as substantially equivalent to K133130 (Cook, Inc., 2015) after a 118-day review. Its family tree reaches back 3 generations to 2001. 3 of the 7 devices in its family, counting itself, have a Class I recall.
- Decided
- Oct 27, 2016
- Review
- 118 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K011664 (2001). 6 ancestors in all, the oldest K882796 (1988). No later device cites it as a predicate yet. 3 of the 7 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK011664 Imager II Angiographic CatheterBoston Scientific/Medi-Tech · 2001 · Recalled
- 2 generations backK121694 Imager II Angiographic CatheterBoston Scientific Corp · 2012 · Recalled (Class I)
- 1 generation backK133130 Beacon Tip Torcon NB Advantage Catheter, Torcon NB Advantage CatheterCook, Inc. · 2015 · Recalled (Class I)
- This deviceK161822 Torcon NB Advantage CathetersCook Incorporated · 2016
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011664 | Imager II Angiographic Catheter | Boston Scientific/Medi-Tech | 2001 | 2 |
| −2 | K121694 | Imager II Angiographic Catheter | Boston Scientific Corp | 2012 | Class I |
| −1 | K133130 | Beacon Tip Torcon NB Advantage Catheter, Torcon NB Advantage Catheter | Cook, Inc. | 2015 | Class I |
| 0 (this device) | K161822 | Torcon NB Advantage Catheters | Cook Incorporated | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 2002 | 1 | 0 |
| 2012 | 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.
3 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? (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 |
|---|---|---|---|
| * | K133130 | Beacon Tip Torcon NB Advantage Catheter, Torcon NB Advantage CatheterSummary page 4…ed’s Torcon NB® Advantage Catheters have an identical intended use to the predicate device, Beacon Tip Torcon NB® Advantage Catheters and Torcon NB® Advantage Catheters (K133130). Additionally, the principles of operation, technological characteristics, materials, and manufacturing processes of the Torcon… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 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.
- K133130Beacon Tip Torcon NB Advantage Catheter, Torcon NB Advantage CatheterCook, Inc. · 2015 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K122937Slip-Cath Beacon Tip Catheter Model SCBR (Product Prefix), Shuttle Select Slip-Cath Catheter Model SCBR…Cook, Inc. · 2012 · 2 generations back · ◆ in the 2012 ancestors bar of FIG. 12 Class I recalls
- K121694Imager II Angiographic CatheterBoston Scientific Corp · 2012 · 2 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 5 of the 6 ancestors have a recall of any class; 3 have a Class I recall.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Torcon NB® Advantage Catheters are intended for use in the peripheral and coronary vascular system including the carotid arteries in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161822 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161822: Torcon NB Advantage Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161822
Report an extraction error
Are you the manufacturer?
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