# K964289: Eye Fixation Speculum

- Pathway: 510(k) (Traditional)
- Applicant: Eyefix, Inc.
- Decided: Dec 17, 1996 after 50 days
- Product code: HNC (Specula, 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
Longest line of descent: 1 generation back to K864520 (1987). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K864520: Barron Rotary Blade Trephine Using Hessburg-Barron, Precision Instruments, Inc. (1987) Summary page 1.

## Cited in the summary but kept off the family tree
- K903322: Lid-Set Eyelid Retractor. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K981235: Oculostat (1998), 0 descendants of its own

## Indications for use
The Eye Fixation Speculum, by eyeFix™, Inc. is intended to reduce eye movement and stabilize the eye in any procedure in which the globe needs to be immobilized. The device is provided sterile and is disposable for single use only.

Source page: https://510kreport.com/device/K964289
Methodology: https://510kreport.com/methodology