# K221042: Renova RP Centesis Pump

- Pathway: 510(k) (Traditional)
- Applicant: Gi Supply, Inc.
- Decided: Apr 19, 2023 after 376 days
- Product code: BTA (Pump, Portable, Aspiration (Manual Or Powered))
- Device class: 2
- Regulation: 21 CFR 878.4780
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K970186 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970186: GI Supply Paracentesis Pump, Gi Supply (1997) Summary page 4.
- K970187: Runyon Large Volume Paracentesis Kit, Gi Supply (1997) Summary page 7.

## Indications for use
The RenovaRP® Centesis Pump is intended to be used in conjunction with the RenovaRP Tube Set and the RenovaRP Fluid Drainage Bags to remove ascitic fluid from the abdominal cavity for paracentesis, and remove pleural effusion from the thoracic cavity for thoracentesis. The Renova RP Centesis Pump is intended to be used by medically trained healthcare professionals knowledgeable about paracentesis and thoracentesis.

Source page: https://510kreport.com/device/K221042
Methodology: https://510kreport.com/methodology