510(k) · Cleared
ClearedLFR-260
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Evolution Optiks Limited · SBI Manual Refractor, 3d Display
Cleared on May 31, 2024 as substantially equivalent to K936205 (Canon USA, Inc., 1994) after a 245-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- May 31, 2024
- Review
- 245 days
- Class
- Class I
- Product code
- SBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K936205 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK936205 Comprehensive Phoropter, MDR-680Canon USA, Inc. · 1994
- This deviceK233295 LFR-260Evolution Optiks Limited · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K936205 | Comprehensive Phoropter, MDR-680 | Canon USA, Inc. | 1994 | — |
| 0 (this device) | K233295 | LFR-260 | Evolution Optiks Limited | 2024 | — |
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 SBI? 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? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K936205 | Comprehensive Phoropter, MDR-680Summary page 5…: Manual Refractor Regulation Number: 21 C.F.R. 886.1770 Product Code: SBI Regulatory Class: Class I 2. Predicate Device Information 510(k) number K936205 Trade name: Comprehensive Phoropter, MDR-680 Classification Name: Manual Refractor Regulation Number: 21 C.F.R. 88… | 1994 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
How does its category compare?
All SBI devicesSBI Manual Refractor, 3d Display: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · SBI
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · SBI
Too few SBI 510(k)s in any year since 2007 to give a median.
Recalls per year · SBI
No recall names SBI since 2007.
Adverse event reports per year · SBI
No MAUDE report names SBI since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 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 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The LFR-260 is a portable manual refractor providing capabilities to the eyecare provider to perform distance vision testing and subjectively measure sphere, cylinder and axis refractive errors in patients aged from 12-65 years old with healthy visual systems. The device measures spherical error in the range of -10 to +15D and measures cylinder error within +/- 2.5D.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233295 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233295: LFR-260.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233295
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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