Burton Medical Products Corp.: FDA clearances and approvals
Burton Medical Products Corp. has 15 FDA 510(k) clearances (first 1985, latest 2010), across 4 product codes in 2 review panels. Median 510(k) review time: 90 days. openFDA lists 1 product recall by a recalling firm named Burton Medical Products Corp.
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 |
|---|---|---|---|
| KZF | Device, Medical Examination, Ac Powered | 7 | 7 |
| FSY | Light, Surgical, Ceiling Mounted | 5 | 5 |
| FTD | Lamp, Surgical | 2 | 2 |
| FTA | Light, Surgical, Accessories | 1 | 1 |
Review panels
Most recent Burton Medical Products Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K101537 | AIM 200, MAJOR SURGICAL LIGHT | FSY | 2010-09-30 | 119 |
| K042395 | OUTPATIENT III MINOR SURGERY LIGHT | FSY | 2004-12-01 | 90 |
| K000639 | VISIONARY 2000 | FSY | 2000-05-25 | 90 |
| K963682 | GENIE' SINGLE CEILING AND DOUBLE CEILING | FSY | 1996-11-13 | 71 |
| K961843 | GENIE | FSY | 1996-08-22 | 101 |
| K935102 | SATURN LIGHT | FTA | 1994-06-27 | 248 |
| K942553 | GENESIS | FTD | 1994-06-23 | 23 |
| K936088 | WAVE FLUORESCENT MAGNIFIER | KZF | 1994-04-26 | 126 |
| K931645 | HALUX TASKLIGHT | KZF | 1993-08-20 | 140 |
| K901706 | LIGHT, HEAD, EXAMINATION | KZF | 1990-07-19 | 98 |
5 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2004-02-19.
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 Burton Medical Products Corp. have?
Burton Medical Products Corp. has 15 FDA 510(k) clearances (first 1985, latest 2010), across 4 product codes in 2 review panels.
How long does FDA take to clear Burton Medical Products Corp.'s 510(k)s?
The median time from FDA receipt to decision across Burton Medical Products Corp.'s cleared 510(k)s is 90 days.
What devices does Burton Medical Products Corp. make?
Its most frequent FDA product codes are KZF (Device, Medical Examination, Ac Powered, 7); FSY (Light, Surgical, Ceiling Mounted, 5); FTD (Lamp, Surgical, 2).
Has Burton Medical Products Corp. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Burton Medical Products Corp; the most recent began 2004-02-19. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 15 Burton Medical Products Corp. clearances with predicates and recalls
- Run predicate analysis for product code KZF, Burton Medical Products Corp.'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.