# K223854: Unistik® ShieldLock, Unistik VacuFlip

- Pathway: 510(k) (Traditional)
- Applicant: Owen Mumford, Ltd.
- Decided: Jun 30, 2023 after 189 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: 7 generations back to K970259 (1997). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212724: BD Vacutainer UltraTouch Push Button Blood Collection Set, Becton, Dickinson and Company (2022) Summary page 4.
- K982541: Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 & 368608, Becton Dickinson Vacutainer Systems (1998) Summary page 5.

## Indications for use
Unistik® ShieldLock: The Unistik ShieldLock Blood Collection Set is a sterile, multi-sample, single-use 'butterfly' style blood collection set intended to be used by trained healthcare professionals for venipuncture to obtain blood specimens from patients into blood collection tubes or blood culture bottles. When used without the male adapter, the device allows the clinician to obtain a blood specimen from the female hub with a syringe. Unistik® VacuFlip: The Unistik VacuFlip Safety Blood Collection Needle is intended to be used by healthcare professionals with vacuum blood collection tubes for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.

Source page: https://510kreport.com/device/K223854
Methodology: https://510kreport.com/methodology