R.H. Burton Co.: FDA clearances and approvals
R.H. Burton Co. has 19 FDA 510(k) clearances (first 1992, latest 1993), across 11 product codes in 2 review panels. Median 510(k) review time: 194 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | 4 | 4 |
| HLM | Instrument, Measuring, Lens, Ac-Powered | 3 | 3 |
| HKO | Refractometer, Ophthalmic | 2 | 2 |
| HMF | Stand, Instrument, Ac-Powered, Ophthalmic | 2 | 2 |
| HPC | Set, Lens, Trial, Ophthalmic | 2 | 2 |
| HJB | Instrument, Measuring, Corneal Radius | 1 | 1 |
| HKX | Tonometer, Ac-Powered | 1 | 1 |
| HOD | Clamp, Eyelid, Ophthalmic | 1 | 1 |
| HOS | Projector, Ophthalmic | 1 | 1 |
| HRJ | Table, Instrument, Powered, Ophthalmic | 1 | 1 |
Plus 1 more product codes.
Review panels
- Ophthalmic (18)
- Orthopedic (1)
Most recent R.H. Burton Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K924773 | BURTON H- BASE TABLE - MODEL 1990 | HRX | 1993-06-07 | 257 |
| K924786 | BURTON TRIAL LENS SET | HPC | 1993-04-14 | 203 |
| K924783 | BURTON SLIT LAMP - MODEL 850 | HJO | 1993-04-14 | 203 |
| K924774 | BURTON AUTOMATIC PROJECTOR - MODEL CP-40 | HOD | 1993-04-14 | 203 |
| K924790 | BURTON AUTO REFRACTOR - MODEL BAR-7 | HKO | 1993-04-05 | 194 |
| K924788 | BURTON LENSMETER | HLM | 1993-04-05 | 194 |
| K924785 | BURTON RADIUSGAUGE - MODEL 2030 | HLM | 1993-04-05 | 194 |
| K924784 | BURTON PROJECTOR HEAD - MODEL 6000-H | HOS | 1993-04-05 | 194 |
| K924780 | BURTON OPHTHALMIC EXAM UNIT - MODEL 2201 | HMF | 1993-04-05 | 194 |
| K924779 | BURTON KERATOMETER - MODLE 2040 | HJB | 1993-04-05 | 194 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named R.H. Burton Co..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does R.H. Burton Co. have?
R.H. Burton Co. has 19 FDA 510(k) clearances (first 1992, latest 1993), across 11 product codes in 2 review panels.
How long does FDA take to clear R.H. Burton Co.'s 510(k)s?
The median time from FDA receipt to decision across R.H. Burton Co.'s cleared 510(k)s is 194 days.
What devices does R.H. Burton Co. make?
Its most frequent FDA product codes are HJO (Biomicroscope, Slit-Lamp, Ac-Powered, 4); HLM (Instrument, Measuring, Lens, Ac-Powered, 3); HKO (Refractometer, Ophthalmic, 2).
Has R.H. Burton Co. had device recalls?
openFDA lists no recalls under a recalling firm name matching R.H. Burton Co. Related entities may recall under other names.
Next steps
- See all 19 R.H. Burton Co. clearances with predicates and recalls
- Run predicate analysis for product code HJO, R.H. Burton Co.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.