510(k) · Cleared
ClearedProsys Custom Fit Leg Bag with Preattached Adjustable Inlet Tube for Patient Sizing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Convatec, A Division of E.R. Squibb & Sons · FAQ Bag, Urine Collection, Leg, For External Use, Sterile
Cleared on Jul 18, 1996 after a 16-day review. The FDA summary names its predicate without a number.
- Decided
- Jul 18, 1996
- Review
- 16 days
- Class
- Class I
- Product code
- FAQ
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 FAQ? 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 |
|---|---|---|---|
| * | — | ProSys™ Leg Bag (Non-Sterile) 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.
How does its category compare?
All FAQ devicesFAQ Bag, Urine Collection, Leg, For External Use, Sterile: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FAQ
FDA has decided no FAQ device since 2007.
Median 510(k) review, days · FAQ
Too few FAQ 510(k)s in any year since 2007 to give a median.
Recalls per year · FAQ
3in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FAQ
16in 2025
MAUDE reports naming product code FAQ, 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 | 3 |
| 2010 | 0 | — | 0 | 17 |
| 2011 | 0 | — | 2 | 12 |
| 2012 | 0 | — | 0 | 13 |
| 2013 | 0 | — | 0 | 9 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 13 |
| 2017 | 0 | — | 0 | 22 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 70 |
| 2022 | 0 | — | 0 | 48 |
| 2023 | 0 | — | 3 | 36 |
| 2024 | 0 | — | 0 | 42 |
| 2025 | 0 | — | 0 | 16 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Both devices are indicated for the management of urinary incontinence.
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/K962604 · printed Nov 5, 2026
Cite this page
510(k) Report. “K962604: Prosys Custom Fit Leg Bag with Preattached Adjustable Inlet Tube for Patient Sizing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962604
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026