# K021315: Sure-Lok

- Pathway: 510(k) (Abbreviated)
- Applicant: Vital Signs, Inc.
- Decided: Aug 21, 2002 after 118 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K946289 (1995). 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)
- K950098: Needle Safety Cover, Hammer-Plane, Inc. (1995) Summary page 1.
- K946289: Devons Point Lok Needle Protection Device, Devon Industries, Inc. (1995) Summary page 1.

## Indications for use
The Sure-LokTM secondary needle kit contains a needle w/Sure-LokTM adapter, sheath, and base stand that is intended for use with standard her-lock and luer-slip arterial blood gas collection syringes. Following sampling, the needle is inserted into the sheath whereby the Sure-LokTM adapter engages with the sheath, preventing needle exposure.

Source page: https://510kreport.com/device/K021315
Methodology: https://510kreport.com/methodology