510(k) · Cleared
ClearedUniversa Percultaneous Drainage Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · FEW Catheter, Malecot
Cleared on Nov 18, 2014 as substantially equivalent to K931195 (Cook Urological, Inc., 1993) and 1 other predicate after a 309-day review. Its family tree reaches back 1 generation to 1981. 6 later devices descend from it.
- Decided
- Nov 18, 2014
- Review
- 309 days
- Class
- Class II
- Product code
- FEW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K810368 (1981). 2 ancestors in all. 6 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK810368 Vance Percutaneous Malecot NephrostomyVance Products, Inc. · 1981 · Recalled
- This deviceK140085 Universa Percultaneous Drainage CatheterCook Incorporated · 2014
- Descendant · cites it directly · 1 of its ownK181097 Cook Cystostomy Catheter SetCook Incorporated · 2019
- Descendant · 2 generations on · 0 of its ownK240514 AMT Low-Profile Suprapubic Catheter & Drainage SetApplied Medical Technology, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK211911 Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous…Coloplast Corp. · 2022
- Descendant · cites it directly · 0 of its ownK191498 Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with…Cook Incorporated · 2020
- Descendant · cites it directly · 0 of its ownK181735 Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy…Cook Incorporated · 2019 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K181097Cook Cystostomy Catheter SetCook Incorporated · 2019 · cites it directly1descendant
- K240514AMT Low-Profile Suprapubic Catheter & Drainage SetApplied Medical Technology, Inc. · 2024 · 2 generations on0descendants
- K211911Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits…Coloplast Corp. · 2022 · cites it directly0descendants
- K191498Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane…Cook Incorporated · 2020 · cites it directly0descendants
- K181735Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent SetCook Incorporated · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K810368 | Vance Percutaneous Malecot Nephrostomy | Vance Products, Inc. | 1981 | 3 |
| 0 (this device) | K140085 | Universa Percultaneous Drainage Catheter | Cook Incorporated | 2014 | — |
| +1 | K181097 | Cook Cystostomy Catheter Set | Cook Incorporated | 2019 | — |
| +2 | K240514 | AMT Low-Profile Suprapubic Catheter & Drainage Set | Applied Medical Technology, Inc. | 2024 | — |
| +1 | K211911 | Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy… | Coloplast Corp. | 2022 | — |
| +1 | K191498 | Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc… | Cook Incorporated | 2020 | — |
| +1 | K181735 | Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set | Cook Incorporated | 2019 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 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 FEW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K931195 | Percutaneous Drainage Loop Catheter SetSummary page 4…on: 21 CFR §876.5090 Product Code: FEW, KOB, LJE Predicate Devices: Percutaneous Drainage Loop Catheter Sets K931195, December 22, 1993 Vance Percutaneous Malecot Nephrostomy Catheter Set K810368, March 20, 1981… | 1993 |
| * | K810368 | Vance Percutaneous Malecot NephrostomySummary page 4…FEW, KOB, LJE Predicate Devices: Percutaneous Drainage Loop Catheter Sets K931195, December 22, 1993 Vance Percutaneous Malecot Nephrostomy Catheter Set K810368, March 20, 1981 Company Confidential Cook Incorporated… | 1981 |
What descends from it? (6)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181097 | Cook Cystostomy Catheter Set | 2019 | 1 |
| K211911 | Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits… | 2022 | 0 |
| K191498 | Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane… | 2020 | 0 |
| K181735 | Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set | 2019 | 0 |
| K180029 | Malecot Nephrostomy Catheter/Stent Set | 2018 | 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?
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K181097 (Cook Incorporated, 2019) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FEW devicesFEW Catheter, Malecot: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · FEW
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · FEW
Too few FEW 510(k)s in any year since 2007 to give a median.
Recalls per year · FEW
No recall names FEW since 2007.
Adverse event reports per year · FEW
1in 2023
MAUDE reports naming product code FEW, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Universa® Loop Drainage Catheter Set is intended to provide percutaneous urine drainage from the genitourinary system.
The Universa® Malecot Drainage Catheter Set is intended to provide percutaneous urine drainage from the genitourinary system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140085 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140085: Universa Percultaneous Drainage Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140085
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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