# K970370: TSK Sterijekt Premium Disposable Hypodermic Needle

- Pathway: 510(k) (Traditional)
- Applicant: Tsk Laboratory, Japan
- Decided: Apr 10, 1997 after 69 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Becton Dickinson & Company B-D PrecisionGlide needles: named in the summary without a submission number

## Most influential descendants
- K151571: Mini Needle (2015), 6 descendants of its own
- K170768: Mini Needle (2017), 5 descendants of its own
- K183016: SteriCap Mini Needle (2019), 4 descendants of its own
- K212805: SteriCap Mini Needle and Standard Needles (2021), 3 descendants of its own
- K230959: VitreJect® Needle; OcuSafe® Needle (2023), 2 descendants of its own

## Recalls of this device
- Dec 16, 2011 · Not classified · Z-0694-2012: Merz Aesthetics is initiating a medical device recall on TSK Closed Tip Cannula (27GA x 25mm) due to a labeling error on the secondary (outer) packaging. The outer package label states that the carton

## Indications for use
To inject fluids into, or withdraw fluids from parts of the body below the surface of the skin.

Source page: https://510kreport.com/device/K970370
Methodology: https://510kreport.com/methodology