# K041084: Clip-on Spacer 20%; 40%; 50%

- Pathway: 510(k) (Traditional)
- Applicant: Serono, Inc.
- Decided: Jul 15, 2004 after 80 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
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. The FDA summary names no predicate by number.

## Indications for use
The Clip-On Spacer is designed for use with ®Rebif® pre-filled syringes containing 22 mcg/0.5 mL and 44 mcg/0.5 mL of Rebif during the dose titration stage of therapy. The Clip-On Spacer is designed to aid the user in injecting the appropriate percentage of the total volume contained within the syringe, when less than the full volume of the syringe is prescribed.

Source page: https://510kreport.com/device/K041084
Methodology: https://510kreport.com/methodology