# K853598: Ophthalmic Knife W/Removale Depth Guide

- Pathway: 510(k) (Traditional)
- Applicant: Myocure, Inc.
- Decided: Nov 4, 1985 after 69 days
- Product code: HNN (Knife, Ophthalmic)
- Device class: 1
- Regulation: 21 CFR 886.4350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
31 later devices descend from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K101626: Lensx Laser System (2010), 30 descendants of its own
- K113151: Ifs Laser System (2012), 19 descendants of its own
- K120732: Lenssx Laser System (2012), 12 descendants of its own
- K141476: Wavelight FS200 Laser System (2014), 8 descendants of its own
- K120426: Victus Laser Platform (2012), 7 descendants of its own

Source page: https://510kreport.com/device/K853598
Methodology: https://510kreport.com/methodology