510(k) · Cleared

Recalled · 2009

Percutaneous Nephrostomy Set

K820867510(k) TraditionalCleared Apr 13, 198215-day reviewClass I21 CFR 878.4200Recalls 4

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Van-Tec, Inc. · GBO Catheter, Nephrostomy, General & Plastic Surgery

Cleared on Apr 13, 1982 after a 15-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 4 times.

Decided: Apr 13, 1982
Review: 15 days
Class: Class I
Product code: GBO
Recalls: 4
Predicates: 0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K820867Source: FDA 510(k) database · How lineage is built

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.

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Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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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?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 18, 2009	Not classified	Z-1346-2009	Labeling False and Misleading	Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex Drainage Catheter Family (Pigtail Style). During the attempted removal of the device, sutures were separated from the catheter and…
Mar 18, 2009	Not classified	Z-1339-2009	Labeling False and Misleading	Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex Drainage Catheter Family (Pigtail Style). During the attempted removal of the device, sutures were separated from the catheter and…
Mar 18, 2009	Not classified	Z-1345-2009	Labeling False and Misleading	Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex Drainage Catheter Family (Pigtail Style). During the attempted removal of the device, sutures were separated from the catheter and…
Jun 25, 2004	Not classified	Z-1106-04	Other	Mislabeled as to size; 10FR are labeled as 8FR.

No ancestor or descendant has a Class I recall.

How does its category compare?

All GBO devices

GBO Catheter, Nephrostomy, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GBO

FDA has decided no GBO device since 2007.

Median 510(k) review, days · GBO

Too few GBO 510(k)s in any year since 2007 to give a median.

Recalls per year · GBO

1in 2019

2007high 1 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GBO

68in 2025

2007high 435 (2018) · low 4 (2012)2025

MAUDE reports naming product code GBO, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	14
2008	—	0	11
2009	—	1	5
2010	—	0	8
2011	—	0	6
2012	—	0	4
2013	—	0	6
2014	—	0	20
2015	—	0	47
2016	—	0	38
2017	—	0	422
2018	—	0	435
2019	—	1	175
2020	—	0	127
2021	—	0	115
2022	—	0	121
2023	—	0	145
2024	—	0	32
2025	—	0	68
2026	—	0	—

https://510kreport.com/device/K820867 · printed Nov 6, 2026

Cite this page

510(k) Report. “K820867: Percutaneous Nephrostomy Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K820867

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Record history

FDA decision record loaded May 2, 2026
Page last updated Nov 3, 2026