# K970187: Runyon Large Volume Paracentesis Kit

- Pathway: 510(k) (Traditional)
- Applicant: Gi Supply
- Decided: Feb 14, 1997 after 28 days
- Product code: LRO (General Surgery Tray)
- Device class: 2
- Regulation: 21 CFR 878.4370
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K221042: Renova RP Centesis Pump (2023), 0 descendants of its own

## Recalls of this device
- Jan 28, 2016 · Class II · Z-1047-2016: Customers have reported that the pinch clamp on the RP Bag was missing. Ascetic fluid from the abdominal cavity may splash User if bag is not clamped prior to removal.

Source page: https://510kreport.com/device/K970187
Methodology: https://510kreport.com/methodology