510(k) · Cleared
ClearedTopcon Model BV-1000 Automated Subjective Refraction System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Topcon Medical Systems, Inc. · HKO Refractometer, Ophthalmic
Cleared on Dec 19, 2003 after a 189-day review. The FDA summary names no predicate by number.
- Decided
- Dec 19, 2003
- Review
- 189 days
- Class
- Class I
- Product code
- HKO
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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 HKO? 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?
The FDA summary names no predicate by number.
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.
How does its category compare?
All HKO devicesHKO Refractometer, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HKO
FDA has decided no HKO device since 2007.
Median 510(k) review, days · HKO
Too few HKO 510(k)s in any year since 2007 to give a median.
Recalls per year · HKO
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HKO
36in 2025
MAUDE reports naming product code HKO, 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 | 4 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 17 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 9 |
| 2017 | 0 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 9 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 1 | 7 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 10 |
| 2024 | 0 | — | 0 | 28 |
| 2025 | 0 | — | 0 | 36 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Topcon Model BV-1000 Automated Subjective Refraction System provides
sphere, cylinder and axis measurements of the eye. The BV-1000 assists the eyecare
professional in evaluating pre and post operative eye procedures and is used as an aid in
prescribing eyeglasses and contact lenses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031831 · printed Nov 4, 2026
Cite this page
510(k) Report. “K031831: Topcon Model BV-1000 Automated Subjective Refraction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K031831
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026