510(k) · Cleared
Recalled · Class I · 2026White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter
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 May 26, 2017 as substantially equivalent to K122937 (Cook, Inc., 2012) after a 267-day review. Its family tree reaches back 2 generations to 1988. 3 of the 4 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled once, including a Class I recall.
- Decided
- May 26, 2017
- Review
- 267 days
- Class
- Class II
- Product code
- DQO
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 2 generations to K882796 (1988). 1 later device descends from it, 1 citing it directly. 3 of the 4 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK882796 Slip-Coat (TM) CathetersCook, Inc. · 1988
- 1 generation backK122937 Slip-Cath Beacon Tip Catheter Model SCBR (Product Prefix), Shuttle…Cook, Inc. · 2012 · Recalled (Class I)
- This deviceK162448 White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava…Cook Incorporated · 2017
- Descendant · cites it directly · 0 of its ownK173289 Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip…Cook Incorporated · 2017 · Recalled (Class I)
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K173289Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and Shuttle…Cook Incorporated · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K882796 | Slip-Coat (TM) Catheters | Cook, Inc. | 1988 | — |
| −1 | K122937 | Slip-Cath Beacon Tip Catheter Model SCBR (Product Prefix), Shuttle Select… | Cook, Inc. | 2012 | Class I |
| 0 (this device) | K162448 | White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing… | Cook Incorporated | 2017 | — |
| +1 | K173289 | Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and… | Cook Incorporated | 2017 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 |
|---|---|---|---|
| * | K122937 | Slip-Cath Beacon Tip Catheter Model SCBR (Product Prefix), Shuttle Select Slip-Cath…Summary page 4…DQO (21 CFR §870.1200) Predicate Device The Sizing Catheters are substantially equivalent to the Slip-Cath® Beacon® Tip Catheter cleared under 510(k) number K122937. Comparison to Predicate It has been demonstrated that the Sizing Catheters and the predicate device are substan… | 2012 |
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 |
|---|---|---|---|
| K173289 | Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and Shuttle… Class I | 2017 | 0 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 2, 2026 | Class I | Z-1935-2026 | Under Investigation by firm | Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario… |
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.
- K122937Slip-Cath Beacon Tip Catheter Model SCBR (Product Prefix), Shuttle Select Slip-Cath Catheter Model SCBR…Cook, Inc. · 2012 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
- K173289Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and Shuttle Select Slip-Cath…Cook Incorporated · 2017 · Cites it directly · ◆ in the 2017 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 29 years and passes through 2 companies; a new generation was cleared every 24.4 years on median.
- 1 of the 2 ancestors has a recall of any class; 1 has a Class I recall.
- Of its descendants, K173289 (Cook Incorporated, 2017) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K122937.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
Sizing catheters are intended for use 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. Sizing catheters have marker bands that can be used for anatomical measurements.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162448 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162448: White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162448
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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