510(k) · Cleared
ClearedDenver Ascites Shunts, Denver Ascites Shunt Percutaneous Access Kits
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Denver Biomaterials, Inc. · KPM Shunt, Peritoneal
Cleared on Mar 17, 1998 as substantially equivalent to K894756 (Codman & Shurtleff, Inc., 1989) and 1 other predicate after a 208-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Mar 17, 1998
- Review
- 208 days
- Class
- Class II
- Product code
- KPM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K894756 (1989). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK894756 Denver Peritoneo-Venus ShuntCodman & Shurtleff, Inc. · 1989
- This deviceK973129 Denver Ascites Shunts, Denver Ascites Shunt Percutaneous Access KitsDenver Biomaterials, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K894756 | Denver Peritoneo-Venus Shunt | Codman & Shurtleff, Inc. | 1989 | — |
| 0 (this device) | K973129 | Denver Ascites Shunts, Denver Ascites Shunt Percutaneous Access Kits | Denver Biomaterials, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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? (3)
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 |
|---|---|---|---|
| * | K894756 | Denver Peritoneo-Venus ShuntSummary page 1…rcutaneous Access Kits. The devices have the same intended use, materials, configuration and dimensional specifications as the currently marketed Denver® Ascites Shunts (K894756) and Denver® Ascites Shunt Percutaneous Access Kits (K913728). The devices differ in that: 1) The devices covered by this submi… | 1989 |
| * | K913728 | Denver (R) Peritoneo-Subclavian ShuntSummary page 1…e, materials, configuration and dimensional specifications as the currently marketed Denver® Ascites Shunts (K894756) and Denver® Ascites Shunt Percutaneous Access Kits (K913728). The devices differ in that: 1) The devices covered by this submission undergo a surface treatment as part of the manufacturin… | 1994 |
| * | — | Smith & Nephew Ventilation Tubes 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?
- None of the 2 ancestors has a 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?
Drainage of persistent ascites from the abdominal cavity into the venous system, for use in 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 which is non-responsive to standard medical management
*primary or metastatic intra-abdominal neoplasms with massive ascites to help relieve intra-abdominal pressure
*persistent ascites 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/K973129 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973129: Denver Ascites Shunts, Denver Ascites Shunt Percutaneous Access Kits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973129
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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