510(k) · Cleared
ClearedDenver Ascites Shunt and Percutaneous Access Kit with Ascities Shunt
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 Jul 12, 2001 after a 28-day review. The FDA summary names no predicate by number. 1 later device descends from it.
- Decided
- Jul 12, 2001
- Review
- 28 days
- Class
- Class II
- Product code
- KPM
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK011862 Denver Ascites Shunt and Percutaneous Access Kit with Ascities ShuntDenver Biomedical, Inc. · 2001
- Descendant · cites it directly · 0 of its ownK170405 BD Curve Ascites ShuntCare Fusion · 2017
Most influential descendants
Showing 1 of 1 · See all- K170405BD Curve Ascites ShuntCare Fusion · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011862 | Denver Ascites Shunt and Percutaneous Access Kit with Ascities Shunt | Denver Biomedical, Inc. | 2001 | — |
| +1 | K170405 | BD Curve Ascites Shunt | Care Fusion | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 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?
The FDA summary names no predicate by number.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170405 | BD Curve Ascites Shunt | 2017 | 0 |
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?
- Of its descendants, K170405 (Care Fusion, 2017) has gone furthest, with 0 descendants of its own.
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?
Peritoneo-venous shunting is indicated for patients with:
. chronic liver disease whose ascites has not responded to surgical correction of their
portal hypertension nor to standard medical management.
. persistent ascites who are not considered candidates for portal-venous shunting.
. persistent ascites that is non-responsive to standard medical management..
. primary or metastatic intra-abdominal neoplasms with massive ascites to help relieve
intra-abdominal pressure.
Peritoneo-venous shunting should also be considered for patients with hepatorenal
syndrome, chylous ascites and idiopathic ascites.
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/K011862 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011862: Denver Ascites Shunt and Percutaneous Access Kit with Ascities Shunt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011862
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026