# K954842: D.O.R.C. Vfi/Vfe System

- Pathway: 510(k) (Traditional)
- Applicant: Dutch Ophthalmic USA, Inc.
- Decided: Apr 15, 1996 after 175 days
- Product code: KYG (Device, Irrigation, Ocular Surgery)
- Device class: 1
- Regulation: 21 CFR 886.4360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K050716: Iscience Surgical Viscoinjector (2005), 11 descendants of its own
- K132494: Viscoelastic Injector (2013), 10 descendants of its own
- K143205: Viscoelastic Injector (2014), 9 descendants of its own
- K171905: VISCO 360 Viscosurgical System (2017), 8 descendants of its own
- K173332: OMNI Surgical System (2017), 6 descendants of its own

Source page: https://510kreport.com/device/K954842
Methodology: https://510kreport.com/methodology