510(k) · Cleared
ClearedMedline Premium Leg Bag, Medline Fabric Bac Leg Bag, Medline Urinary Leg Bag
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industries, Inc. · KNX Collector, Urine, (And Accessories) For Indwelling Catheter
Cleared on Dec 11, 1997 as substantially equivalent to K780032 (C.R. Bard, Inc., 1978) after a 128-day review. Its family tree reaches back 1 generation to 1978.
- Decided
- Dec 11, 1997
- Review
- 128 days
- Class
- Class II
- Product code
- KNX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K780032 (1978). No later device cites it as a predicate yet.
- Root · 1 generation backK780032 Urinary Leg BagC.R. Bard, Inc. · 1978 · Recalled
- This deviceK972887 Medline Premium Leg Bag, Medline Fabric Bac Leg Bag, Medline Urinary…Medline Industries, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K780032 | Urinary Leg Bag | C.R. Bard, Inc. | 1978 | 1 |
| 0 (this device) | K972887 | Medline Premium Leg Bag, Medline Fabric Bac Leg Bag, Medline Urinary Leg Bag | Medline Industries, Inc. | 1997 | — |
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? (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 |
|---|---|---|---|
| * | K780032 | Urinary Leg BagSummary page 1…nded to be connected to an indwelling catheter) SUBSTANTIAL EQUIVALENCE: Medline claims substantial equivalence to: Mediine’s Urine Collector Leg Bag Bard's Leg Bags (K780032) These new devices are identical to what Medline is currently marketing. The only difference between the devices that are curren… | 1978 |
| * | — | Medline’s Urine Collector Leg Bag Named without a submission number |
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 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?
These devices are indicated for use by incontinent persons or persons with other medical conditions that warrant the use of a leg bag and are intended to collect urine. They may be connected to either an indwelling or non-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/K972887 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972887: Medline Premium Leg Bag, Medline Fabric Bac Leg Bag, Medline Urinary Leg Bag.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972887
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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