510(k) · Cleared
ClearedEye Fixation Speculum
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eyefix, Inc. · HNC Specula, Ophthalmic
Cleared on Dec 17, 1996 as substantially equivalent to K864520 (Precision Instruments, Inc., 1987) after a 50-day review. Its family tree reaches back 1 generation to 1987. 1 later device descends from it.
- Decided
- Dec 17, 1996
- Review
- 50 days
- Class
- Class I
- Product code
- HNC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K864520 (1987). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K981235OculostatLaser Center Dev. Corp. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K864520 | Barron Rotary Blade Trephine Using Hessburg-Barron | Precision Instruments, Inc. | 1987 | — |
| 0 (this device) | K964289 | Eye Fixation Speculum | Eyefix, Inc. | 1996 | — |
| +1 | K981235 | Oculostat | Laser Center Dev. Corp. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HNC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| 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…lent to the indication for use of the Lid-Set Eyelid Retractor manufactured by Universi, S.A. This device was determined by FDA to be exempt from 510(k) notification per K903322. The Eye Fixation Speculum is substantially equivalent to the stabilization method (technology) used in numerous manual opthalmic… | |
| * | K864520 | Barron Rotary Blade Trephine Using Hessburg-BarronSummary page 1…ed in numerous manual opthalmic instruments such as the Hessburg-Barron Vacuum Trephine as manufactured by Precision Instruments, Inc. This device was cleared by FDA in K864520. Additional products in the same family line were cleared under K843048 and K923540. DESCRIPTION of the DEVICE: The Eye Fixation… | 1987 |
| † | K843048 | Ring Supported Trephine for Cornea Trans | 1984 |
| † | K923540 | Unnamed device |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K981235 | Oculostat | 1998 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All HNC devicesHNC Specula, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HNC
FDA has decided no HNC device since 2007.
Median 510(k) review, days · HNC
Too few HNC 510(k)s in any year since 2007 to give a median.
Recalls per year · HNC
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HNC
1in 2025
MAUDE reports naming product code HNC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 1 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K964289 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964289: Eye Fixation Speculum.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964289
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026