# K955164: S.a.R.S. II (Semi-Automatic-Reconstituting-System)

- Pathway: 510(k) (Traditional)
- Applicant: Habley Medical Technology Corp.
- Decided: Mar 20, 1996 after 128 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- 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 K941545 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941545: Advantage Syringe, Bd Becton Dickinson Vacutainer Systems Preanalytic (1994) Summary page 2.
- (no number) Vetter Lyo-Ject System: named in the summary without a submission number
- (no number) UpJohn Mix-O-Vial: named in the summary without a submission number

## Indications for use
The Habley Medical Technology Corporation S.A.R.S. II™ (Semi-Automatic-Reconstituting-System) is intended for the mixing of an approved two component drug and for delivering the mixed drug (according to the drug labeling) to a receptacle such as an IV Bag for subsequent patient administration.

Source page: https://510kreport.com/device/K955164
Methodology: https://510kreport.com/methodology