510(k) · Cleared
ClearedDenver Pleural Effusion Shunt and Denver Pleural Effusion Shunt with External Pump Chamber
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Denver Biomedical, Inc. · KPM Shunt, Peritoneal
Cleared on Oct 4, 2001 after a 79-day review. The FDA summary names its predicate without a number.
- Decided
- Oct 4, 2001
- Review
- 79 days
- Class
- Class II
- Product code
- KPM
- 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 KPM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KPM device
- #1 K231096 Automatic Continuous Effusion Shunt (ACES)…score 5.9 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | — | Denver Pleural Effusion Shunt Named without a submission number | |
| * | — | Denver Pleural Effusion Shunt with External Pump Chamber 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 KPM devicesKPM Shunt, Peritoneal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KPM
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · KPM
Too few KPM 510(k)s in any year since 2007 to give a median.
Recalls per year · KPM
No recall names KPM since 2007.
Adverse event reports per year · KPM
1in 2025
MAUDE reports naming product code KPM, 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 | 2 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 68 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Denver Pleural Effusion Shunt is indicated for use in patients with
* chylothorax
* intractable aseptic pleural effusion
The Denver Pleural Effusion Shunt with External Pump Chamber is indicated for adult, pediatric, and neonatal patients with:
* chylothorax
* intractable pleural effusion
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/K012235 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012235: Denver Pleural Effusion Shunt and Denver Pleural Effusion Shunt with External Pump Chamber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012235
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026