510(k) · Decided
DecidedCook Cystostomy Catheter Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · KOB Catheter, Suprapubic (And Accessories)
Cleared on Jan 18, 2019 as substantially equivalent to K014002 (Fortune Medical Instrument Corp., 2002) and 1 other predicate after a 267-day review. Its family tree reaches back 2 generations to 1981. 1 later device descends from it.
- Decided
- Jan 18, 2019
- Review
- 267 days
- Class
- Class II
- Product code
- KOB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K810368 (1981). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK810368 Vance Percutaneous Malecot NephrostomyVance Products, Inc. · 1981 · Recalled
- 1 generation backK140085 Universa Percultaneous Drainage CatheterCook Incorporated · 2014
- This deviceK181097 Cook Cystostomy Catheter SetCook Incorporated · 2019
- Descendant · cites it directly · 0 of its ownK240514 AMT Low-Profile Suprapubic Catheter & Drainage SetApplied Medical Technology, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K240514AMT Low-Profile Suprapubic Catheter & Drainage SetApplied Medical Technology, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K810368 | Vance Percutaneous Malecot Nephrostomy | Vance Products, Inc. | 1981 | 3 |
| −1 | K140085 | Universa Percultaneous Drainage Catheter | Cook Incorporated | 2014 | — |
| 0 (this device) | K181097 | Cook Cystostomy Catheter Set | Cook Incorporated | 2019 | — |
| +1 | K240514 | AMT Low-Profile Suprapubic Catheter & Drainage Set | Applied Medical Technology, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
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.
Planning a device in KOB? 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 KOB device
- #1 K240514 AMT Low-Profile Suprapubic Catheter & Drainage…score 8.9 · 3 generations · no Class I recall
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K014002 | All Silicone Supra-Pubia Catheter, Models 4880/4890Summary page 4…vice Classification: Class II Review Panel: Gastroenterology/Urology Predicate Devices: All Silicone Supra-Pubia Catheter, Models 4880/4890 (K014002) Universa® Percutaneous Drainage Catheter Set (Malecot Suprapubic Set) (K140085) Device Description: The Cook® Cystostomy Cathe… | 2002 |
| * | K140085 | Universa Percultaneous Drainage CatheterSummary page 4…rology/Urology Predicate Devices: All Silicone Supra-Pubia Catheter, Models 4880/4890 (K014002) Universa® Percutaneous Drainage Catheter Set (Malecot Suprapubic Set) (K140085) Device Description: The Cook® Cystostomy Catheter Set is composed of a single-lumen silicone catheter available in 8 to 12 Fren… | 2014 |
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 |
|---|---|---|---|
| K240514 | AMT Low-Profile Suprapubic Catheter & Drainage Set | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 38 years and passes through 2 companies; a new generation was cleared every 33.7 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K240514 (Applied Medical Technology, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K014002.
How does its category compare?
All KOB devicesKOB Catheter, Suprapubic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · KOB
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · KOB
Too few KOB 510(k)s in any year since 2007 to give a median.
Recalls per year · KOB
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KOB
1in 2025
MAUDE reports naming product code KOB, 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 | 0 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 6 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 12 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 12 |
| 2018 | 2 | — | 0 | 18 |
| 2019 | 1 | — | 2 | 4 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Cook® Cystostomy Catheter Set is used for temporary suprapubic urinary diversion and drainage for less than or equal to four weeks.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181097 · printed Nov 5, 2026
Cite this page
510(k) Report. “K181097: Cook Cystostomy Catheter Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K181097
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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