510(k) · Cleared
ClearedWelcon Hue-VU Urinary Drainage Bag
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Welcon, Inc. · KNX Collector, Urine, (And Accessories) For Indwelling Catheter
Cleared on Jul 29, 1997 as substantially equivalent to K780837 (Intermed, Inc., 1978) and 2 other predicates after a 77-day review. Its family tree reaches back 1 generation to 1978.
- Decided
- Jul 29, 1997
- Review
- 77 days
- Class
- Class II
- Product code
- KNX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K780837 (1978). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK780837 Urinary Drainage BagIntermed, Inc. · 1978
- This deviceK971764 Welcon Hue-VU Urinary Drainage BagWelcon, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K780837 | Urinary Drainage Bag | Intermed, Inc. | 1978 | — |
| 0 (this device) | K971764 | Welcon Hue-VU Urinary Drainage Bag | Welcon, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1994 | 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 KNX? 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? (3)
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 |
|---|---|---|---|
| * | K780837 | Urinary Drainage BagSummary page 2…ice classification is Class II, Performance Standards (21CFR 876.5250). Predicate Devices: Urinary Drainage Unit (Catalog #6220) Intermed, Inc. Sparta, New Jersey 07871 K780837 Bard Center Entry Closed System Urinary Drainage Bag (Catalog #153509) Bard Urological Division Covington, GA 30209 K844810/K9… | 1978 |
| * | K844810 | New Bard Infection Control Urinary Drainage BagSummary page 2…) Intermed, Inc. Sparta, New Jersey 07871 K780837 Bard Center Entry Closed System Urinary Drainage Bag (Catalog #153509) Bard Urological Division Covington, GA 30209 K844810/K940206 Product Description: The Welcon Hue-Vu™ Urinary Drainage Bag is a 2000 ml capacity vented vinyl urine collection recept… | 1985 |
| * | K940206 | Bard Urine Collection Products ModificationSummary page 2…med, Inc. Sparta, New Jersey 07871 K780837 Bard Center Entry Closed System Urinary Drainage Bag (Catalog #153509) Bard Urological Division Covington, GA 30209 K844810/K940206 Product Description: The Welcon Hue-Vu™ Urinary Drainage Bag is a 2000 ml capacity vented vinyl urine collection receptacle int… | 1994 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 3 ancestors has a recall.
How does its category compare?
All KNX devicesKNX Collector, Urine, (And Accessories) For Indwelling Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KNX
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · KNX
Too few KNX 510(k)s in any year since 2007 to give a median.
Recalls per year · KNX
1in 2023
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KNX
196in 2025
MAUDE reports naming product code KNX, 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 | 1 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 11 |
| 2011 | 1 | — | 3 | 7 |
| 2012 | 0 | — | 0 | 16 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 15 |
| 2015 | 0 | — | 0 | 21 |
| 2016 | 0 | — | 1 | 82 |
| 2017 | 0 | — | 0 | 154 |
| 2018 | 0 | — | 0 | 190 |
| 2019 | 0 | — | 0 | 235 |
| 2020 | 0 | — | 0 | 215 |
| 2021 | 0 | — | 0 | 209 |
| 2022 | 0 | — | 0 | 167 |
| 2023 | 0 | — | 1 (1) | 178 |
| 2024 | 0 | — | 0 | 162 |
| 2025 | 0 | — | 0 | 196 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
The Welcon Hue-Vu™ Urinary drainage Bag is indicated for use for the collection of urine when used with an indwelling catheter.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971764 · printed Nov 5, 2026
Cite this page
510(k) Report. “K971764: Welcon Hue-VU Urinary Drainage Bag.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K971764
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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