# K230408: K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM)

- Pathway: 510(k) (Traditional)
- Applicant: Sb-Kawasumi Laboratories, Inc.
- Decided: Jun 1, 2023 after 106 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K970259 (1997). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220799: K-SHIELD Zen, Sb-Kawasumi Laboratories, Inc. (2022) Summary page 5.

## Indications for use
K-SHIELD Zen is designed for accessing peripheral veins to collect blood. The Press Button anti-needle stick protector is an integral safety device intended to minimize accidental needlestick injuries.

Source page: https://510kreport.com/device/K230408
Methodology: https://510kreport.com/methodology