# K202325: EasyPoint Blood Collection Plus

- Pathway: 510(k) (Traditional)
- Applicant: Retractable Technologies, Inc.
- Decided: Apr 9, 2021 after 235 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: 2 generations back to K972404 (1997). 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)
- K982541: Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 & 368608, Becton Dickinson Vacutainer Systems (1998) Summary page 4.

## Indications for use
The EasyPoint@ Blood Collection Plus is intended for use with evacuated blood collection tubes for venous blood collection, while aiding in the prevention of needlestick injuries and contaminated needle exposure.

Source page: https://510kreport.com/device/K202325
Methodology: https://510kreport.com/methodology