# K030721: Quick-Tap Paracentesis Tray, Kit & Needle

- Pathway: 510(k) (Special)
- Applicant: Ballard Medical Products
- Decided: Mar 31, 2003 after 24 days
- Product code: LRO (General Surgery Tray)
- Device class: 2
- Regulation: 21 CFR 878.4370
- 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 K950574 (1995). 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)
- K950574: Needle/Cannula, Tri-Med Specialties, Inc. (1995)
- K961863: Paracentesis Trays, Tri-Med, Inc. (1996) Summary page 1.

## Indications for use
The Quick-Tap@ Paracentesis Kit, Tray and Needle are indicated to relieve pressure by draining fluid from the peritoneal space. The fluid may be undergo diagnostic testing to assess for chemistries, infection or abnormal cells.

Source page: https://510kreport.com/device/K030721
Methodology: https://510kreport.com/methodology
