# K200325: Orbit Subretinal Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Orbit Biomedical
- Decided: Jul 14, 2020 after 155 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: 3 generations back to K980069 (1998). 5 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182274: Orbit Subretinal Delivery System, Orbit Biomedical, Inc. (2018) Summary page 4.

## Most influential descendants
- K203264: MicroDose Injector (2021), 2 descendants of its own
- K213467: EVA NEXUS Ophthalmic Surgical System (2022), 1 descendant of its own
- K250501: System Sophi (2025), 0 descendants of its own

## Indications for use
The Orbit Subretinal Delivery System is indicated for microinjection into the subretinal space.

Source page: https://510kreport.com/device/K200325
Methodology: https://510kreport.com/methodology