510(k) · Cleared
Recalled · Class II · 2019Vance Percutaneous Malecot Nephrostomy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vance Products, Inc. · KOB Catheter, Suprapubic (And Accessories)
Cleared on Mar 20, 1981 after a 36-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it. It has been recalled 3 times.
- Decided
- Mar 20, 1981
- Review
- 36 days
- Class
- Class II
- Product code
- KOB
- Recalls
- 3
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK810368 Vance Percutaneous Malecot NephrostomyVance Products, Inc. · 1981
- 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) | K810368 | Vance Percutaneous Malecot Nephrostomy | Vance Products, Inc. | 1981 | — |
| +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 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?
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 22, 2019 | Class II | Z-1370-2019 | Error in labeling | Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instructions for Use (IFU) did not include a warning for stent knotting. |
| Jan 4, 2019 | Class II | Z-0968-2020 | Process control | The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip. |
| Jan 4, 2019 | Class II | Z-0969-2020 | Process control | The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip. |
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 KOB devicesKOB Catheter, Suprapubic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K810368 · printed Nov 6, 2026
Cite this page
510(k) Report. “K810368: Vance Percutaneous Malecot Nephrostomy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K810368
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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