510(k) · Cleared
Cleared4L Drainage Bag, 4L Bag for Peritoneal Dialysis, 4L Urinary Drainage Bag
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maersk Medical A/S · KNX Collector, Urine, (And Accessories) For Indwelling Catheter
Cleared on Mar 17, 1998 as substantially equivalent to K843480 (Zimmar Consulting, Ltd., 1984) after a 190-day review. Its family tree reaches back 1 generation to 1984.
- Decided
- Mar 17, 1998
- Review
- 190 days
- Class
- Class II
- Product code
- KNX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K843480 (1984). No later device cites it as a predicate yet.
- Root · 1 generation backK843480 Pharma-Plast Urinary Drainage Bag 2000Zimmar Consulting, Ltd. · 1984
- This deviceK973364 4L Drainage Bag, 4L Bag for Peritoneal Dialysis, 4L Urinary Drainage…Maersk Medical A/S · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K843480 | Pharma-Plast Urinary Drainage Bag 2000 | Zimmar Consulting, Ltd. | 1984 | — |
| 0 (this device) | K973364 | 4L Drainage Bag, 4L Bag for Peritoneal Dialysis, 4L Urinary Drainage Bag | Maersk Medical A/S | 1998 | — |
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? (1)
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 |
|---|---|---|---|
| * | K843480 | Pharma-Plast Urinary Drainage Bag 2000Summary page 1…age Bags Haarlev Mark 2 DK - 4652 Haarlev, Denmark. 6. Substantial equivalence: The products included in this notification is equivalent to the components described in K843480. 7. Device Description. The general description, operation, construction and use of the Maersk Medical 4L drainage bag has not… | 1984 |
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?
- Its one ancestor has no 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 Maersk Medical 4L drainage bag continue to be intended for collection of fluid which is on its way away from the body. The 4L drainage bag can be used in different treatment procedures within areas as urology and dialysis, but in any case the intended use is the same.
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/K973364 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973364: 4L Drainage Bag, 4L Bag for Peritoneal Dialysis, 4L Urinary Drainage Bag.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973364
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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