510(k) · Cleared
ClearedPercutaneous Drainage Loop Catheter Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Urological, Inc. · KOD Catheter, Urological
Cleared on Dec 22, 1993 after a 288-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Dec 22, 1993
- Review
- 288 days
- Class
- Class II
- Product code
- KOD
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK931195 Percutaneous Drainage Loop Catheter SetCook Urological, Inc. · 1993
- Descendant · cites it directly · 6 of its ownK140085 Universa Percultaneous Drainage CatheterCook Incorporated · 2014
- Descendant · 2 generations on · 1 of its ownK181097 Cook Cystostomy Catheter SetCook Incorporated · 2019
- Descendant · 3 generations on · 0 of its ownK240514 AMT Low-Profile Suprapubic Catheter & Drainage SetApplied Medical Technology, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK211911 Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous…Coloplast Corp. · 2022
- Descendant · 2 generations on · 0 of its ownK191498 Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with…Cook Incorporated · 2020
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K140085Universa Percultaneous Drainage CatheterCook Incorporated · 2014 · cites it directly6descendants
- K181097Cook Cystostomy Catheter SetCook Incorporated · 2019 · 2 generations on1descendant
- K240514AMT Low-Profile Suprapubic Catheter & Drainage SetApplied Medical Technology, Inc. · 2024 · 3 generations on0descendants
- K211911Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits…Coloplast Corp. · 2022 · 2 generations on0descendants
- K191498Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane…Cook Incorporated · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K931195 | Percutaneous Drainage Loop Catheter Set | Cook Urological, Inc. | 1993 | — |
| +1 | K140085 | Universa Percultaneous Drainage Catheter | Cook Incorporated | 2014 | — |
| +2 | K181097 | Cook Cystostomy Catheter Set | Cook Incorporated | 2019 | — |
| +3 | K240514 | AMT Low-Profile Suprapubic Catheter & Drainage Set | Applied Medical Technology, Inc. | 2024 | — |
| +2 | K211911 | Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy… | Coloplast Corp. | 2022 | — |
| +2 | K191498 | Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc… | Cook Incorporated | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KOD? 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 KOD device
- #1 K251864 Rubber Utility Catheterscore 10.9 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140085 | Universa Percultaneous Drainage Catheter | 2014 | 6 |
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?
- Of its descendants, K140085 (Cook Incorporated, 2014) has gone furthest, with 6 descendants of its own.
How does its category compare?
All KOD devicesKOD Catheter, Urological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KOD
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · KOD
251in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KOD
1in 2023
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KOD
1,389in 2025
MAUDE reports naming product code KOD, 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 | 180 |
| 2008 | 2 | — | 0 | 102 |
| 2009 | 1 | — | 15 | 183 |
| 2010 | 1 | — | 1 | 228 |
| 2011 | 2 | — | 47 | 209 |
| 2012 | 0 | — | 2 | 165 |
| 2013 | 0 | — | 0 | 393 |
| 2014 | 1 | — | 0 | 226 |
| 2015 | 0 | — | 0 | 418 |
| 2016 | 2 | — | 1 | 284 |
| 2017 | 1 | — | 0 | 1,873 |
| 2018 | 6 | 251 | 0 | 1,179 |
| 2019 | 1 | — | 1 | 1,167 |
| 2020 | 0 | — | 0 | 1,370 |
| 2021 | 1 | — | 0 | 1,388 |
| 2022 | 2 | — | 3 | 1,280 |
| 2023 | 0 | — | 1 (1) | 1,160 |
| 2024 | 0 | — | 0 | 1,259 |
| 2025 | 0 | — | 0 | 1,389 |
| 2026 | 1 | — | 1 | — |
https://510kreport.com/device/K931195 · printed Nov 6, 2026
Cite this page
510(k) Report. “K931195: Percutaneous Drainage Loop Catheter Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K931195
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026