510(k) · Decided
DecidedCook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · MPB Catheter, Hemodialysis, Non-Implanted
Cleared on Jan 6, 2017 as substantially equivalent to K122091 (Cook, Inc., 2013) after a 219-day review. Its family tree reaches back 3 generations to 1990. 3 of the 5 devices in its family, counting itself, have a Class I recall.
- Decided
- Jan 6, 2017
- Review
- 219 days
- Class
- Class II
- Product code
- MPB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K895417 (1990). 4 ancestors in all. No later device cites it as a predicate yet. 3 of the 5 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK895417 Arrow Large-Bore Dual Lumen Hemodialysis KitArrow Intl., Inc. · 1990 · Recalled (Class I)
- 2 generations backK993933 14 FR Two-Lumen Hemodialysis Catherization Kit with Blue Flextip…Arrow Intl., Inc. · 2000 · Recalled (Class I)
- 1 generation backK122091 Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray Cook Spectrum…Cook, Inc. · 2013
- This deviceK161504 Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/TrayCook Incorporated · 2017
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 | K895417 | Arrow Large-Bore Dual Lumen Hemodialysis Kit | Arrow Intl., Inc. | 1990 | Class I |
| −2 | K993933 | 14 FR Two-Lumen Hemodialysis Catherization Kit with Blue Flextip Arrowg+Ard… | Arrow Intl., Inc. | 2000 | Class I |
| −1 | K122091 | Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray Cook Spectrum Turbo-Flo… | Cook, Inc. | 2013 | — |
| 0 (this device) | K161504 | Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray | Cook Incorporated | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 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 MPB device
- #1 K250836 14F Duo-Flow® Side X Side Double Lumen Catheterscore 10.1 · 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 |
|---|---|---|---|
| * | K122091 | Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray Cook Spectrum Turbo-Flo HD Acute…Summary page 5…sories Classification Name: Catheter, Hemodialysis, Non-implanted Regulation: 21 CFR §876.5540 Product Code: MPB Predicate Device: K122091 – Cook Turbo-Flo® HD Acute Hemodialysis Catheter Set/Tray Device Description: The Cook Turbo-Flo® HD Acute Hemodialysis Catheter… | 2013 |
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.
- K99393314 FR Two-Lumen Hemodialysis Catherization Kit with Blue Flextip Arrowg+Ard Blue Catheter for High Volume…Arrow Intl., Inc. · 2000 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K900263Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 1990 · 3 generations back · ◆ in the 1990 ancestors bar of FIG. 12 Class I recalls
- K895417Arrow Large-Bore Dual Lumen Hemodialysis KitArrow Intl., Inc. · 1990 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 10.7 years on median.
- 3 of the 4 ancestors have a recall of any class; 3 have a Class I recall.
How does its category compare?
All MPB devicesMPB Catheter, Hemodialysis, Non-Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · MPB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MPB
205in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MPB
4so far in 2026, the most since 2007
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · MPB
187in 2025
MAUDE reports naming product code MPB, 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 | 3 | 136 | 1 | 41 |
| 2008 | 0 | — | 0 | 147 |
| 2009 | 1 | — | 0 | 166 |
| 2010 | 1 | — | 0 | 60 |
| 2011 | 2 | — | 0 | 74 |
| 2012 | 1 | — | 0 | 78 |
| 2013 | 1 | — | 0 | 124 |
| 2014 | 0 | — | 0 | 82 |
| 2015 | 0 | — | 0 | 51 |
| 2016 | 1 | — | 0 | 70 |
| 2017 | 2 | — | 2 | 86 |
| 2018 | 0 | — | 0 | 120 |
| 2019 | 0 | — | 0 | 119 |
| 2020 | 3 | 205 | 0 | 179 |
| 2021 | 0 | — | 0 | 192 |
| 2022 | 0 | — | 0 | 166 |
| 2023 | 0 | — | 0 | 203 |
| 2024 | 0 | — | 0 | 181 |
| 2025 | 1 | — | 0 | 187 |
| 2026 | 0 | — | 4 (3) | — |
What is it indicated for?
The Cook Turbo-Flo® HD Acute Hemodialysis Catheter Set/Tray is intended for acute hemodialysis, apheresis and hemofiltration via percutaneous insertion into the subclavian, jugular, or femoral veins. The device is a short-term use catheter (less than 30 days).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161504 · printed Nov 4, 2026
Cite this page
510(k) Report. “K161504: Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K161504
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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