# K151991: Safelock Disposable Blood Collection Set, Disposable Blood Collection Set

- Pathway: 510(k) (Traditional)
- Applicant: Jiangyin Caina Technology Co., Ltd.
- Decided: Dec 11, 2015 after 144 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- 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). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020533: Exel Vaculet Blood Collection Set, Exelint Intl. Co. (2002) Summary page 5.
- K031279: Surshield Safety Winged Blood Collection Set, Terumo Medical Products Hangzhou Co., Ltd. (2003) Summary page 6.

## Indications for use
The Disposable blood collection sets are intended to be used with vacuum blood collection tube for venipuncture to collect blood specimens from patients. The Safelock disposable blood collection sets are intended to be used with vacuum blood collection tube for venipuncture to collect blood specimens from patients, and the safety sheath is designed to aid in the reduction of accidental needlesticks.

Source page: https://510kreport.com/device/K151991
Methodology: https://510kreport.com/methodology