# K874063: Enteron Abdominal Paracentesis Tray

- Pathway: 510(k) (Traditional)
- Applicant: Endovations
- Decided: Dec 4, 1987 after 60 days
- Product code: KDD (Kit, Surgical Instrument, Disposable)
- Device class: 1
- Regulation: 21 CFR 878.4800
- Recalls of this device: 3 (1 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.
1 of 2 devices in its family (counting itself) has a Class I recall.

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

## Most influential descendants
- K960456: Denver Paracentesis Needle (60-1200) Denver Paracentesis Needle with Drainage Line (60-1100) Denver Paracentesis Tray (1996), 0 descendants of its own

## Recalls of this device
- Apr 21, 2026 · Class I · Z-2386-2026: Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffect
- Apr 11, 2018 · Class II · Z-1965-2018: Product sterility may be compromised due to unsealed packaging.
- Oct 24, 2017 · Class II · Z-1297-2018: Product packaging may not be completely sealed.

Source page: https://510kreport.com/device/K874063
Methodology: https://510kreport.com/methodology