# K960456: Denver Paracentesis Needle (60-1200) Denver Paracentesis Needle with Drainage Line (60-1100) Denver Paracentesis Tray

- Pathway: 510(k) (Traditional)
- Applicant: Denver Biomaterials, Inc.
- Decided: Apr 1, 1996 after 62 days
- Product code: KDD (Kit, Surgical Instrument, Disposable)
- Device class: 1
- Regulation: 21 CFR 878.4800
- 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 K874063 (1987). 2 ancestors in all.
No later device cites it as a predicate yet.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K874063: Enteron Abdominal Paracentesis Tray, Endovations (1987) Summary page 1.
- K932652: Tri-Med Paracentesis Tray, Tri-Med Specialties, Inc. (1993) Summary page 1.

## Indications for use
The Denver® Paracentesis Needle, Paracentesis Needle with Drainage Line, and Paracentesis Tray are indicated for use in removing fluid from the peritoneal cavity (abdominal paracentesis). They are intended to be used for both diagnostic and therapeutic abdominal paracentesis procedures.

Source page: https://510kreport.com/device/K960456
Methodology: https://510kreport.com/methodology