# K051019: Safety Needle

- Pathway: 510(k) (Traditional)
- Applicant: Sarstedt, Inc.
- Decided: Jul 25, 2005 after 94 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Safety-Needle is a single lumen needle for blood collection via venipuncture in conjunction with the S-Monovette® system. The Safety-Needle needle protector, when activated after removal of the needle from the patient, covers the used needle until it can be properly disposed; therefore, aiding in the prevention of needle stick injuries. The Safety-Needle is individually packaged, sterile, single-use and non-pyrogenic. The Safety-Needle is intended to be used in all hospitals and/or practices where S-Monovettes are used.

Source page: https://510kreport.com/device/K051019
Methodology: https://510kreport.com/methodology