# K012235: Denver Pleural Effusion Shunt and Denver Pleural Effusion Shunt with External Pump Chamber

- Pathway: 510(k) (Special)
- Applicant: Denver Biomedical, Inc.
- Decided: Oct 4, 2001 after 79 days
- Product code: KPM (Shunt, Peritoneal)
- Device class: 2
- Regulation: 21 CFR 876.5955
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Denver Pleural Effusion Shunt: named in the summary without a submission number
- (no number) Denver Pleural Effusion Shunt with External Pump Chamber: named in the summary without a submission number

## Indications for use
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

Source page: https://510kreport.com/device/K012235
Methodology: https://510kreport.com/methodology