510(k) · Cleared
ClearedHigh-Flo Silver Polyethylene 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 Apr 3, 2018 as substantially equivalent to K122937 (Cook, Inc., 2012) after a 214-day review. Its family tree reaches back 2 generations to 1988. 1 of the 3 devices in its family, counting itself, has a Class I recall.
- Decided
- Apr 3, 2018
- Review
- 214 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K882796 (1988). No later device cites it as a predicate yet. 1 of the 3 devices in this family, counting this one, has 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 deviceK172635 High-Flo Silver Polyethylene CatheterCook Incorporated · 2018
Class I recalls in this family
- K122937 Slip-Cath Beacon Tip Catheter Model SCBR…direct predicate · 2012
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K122937 | Slip-Cath Beacon Tip Catheter Model SCBR (Product Prefix), Shuttle Select Slip-Cath…Summary page 4…70.1200) Predicate Device The predicate device of the subject High-Flo Silver Polyethylene Catheter is the Slip- Cath® Beacon® Tip Catheter cleared under 510(k) number K122937. The predicate Slip- Cath® Beacon® Tip Catheter is visually identified by a distal radiopaque tip bonded onto a stainless steel b… | 2012 |
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.
- 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
What does this lineage say?
- The line of descent spans 30 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.
- 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. 2018, 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 High-Flo Silver Polyethylene Catheter is intended for the delivery of contrast media and therapeutic agents to the peripheral, carotid, and coronary vasculature, not including the neurovasculature.
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/K172635 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172635: High-Flo Silver Polyethylene Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172635
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