# K230083: Safira

- Pathway: 510(k) (Traditional)
- Applicant: Medovate Limited
- Decided: Oct 31, 2023 after 293 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K800560 (1980). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153599: Concert Medical Hands-Free Syringe (HFS), Concert Medical, LLC (2016) Summary page 5.

## Indications for use
The Medovate SAFIRA system is intended for use by trained clinicians to administer local anaesthetic below a specified pressure threshold to a target nerve bundle for regional anaesthesia.

Source page: https://510kreport.com/device/K230083
Methodology: https://510kreport.com/methodology