John O. Butler Co.: FDA clearances and approvals
John O. Butler Co. has 6 FDA 510(k) clearances (first 1987, latest 2002), across 4 product codes in 1 review panel. Median 510(k) review time: 82 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 |
|---|---|---|---|
| EFW | Toothbrush, Manual | 2 | 2 |
| JEQ | Toothbrush, Powered | 2 | 2 |
| EJK | Liner, Cavity, Calcium Hydroxide | 1 | 1 |
| JES | Floss, Dental | 1 | 1 |
Review panels
- Dental (6)
Most recent John O. Butler Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K022900 | BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES | JEQ | 2002-11-14 | 72 |
| K974761 | BUTLER ANTIBACTERIAL INTERDENTAL TOOTHBRUSH | EFW | 1998-06-16 | 179 |
| K952091 | VUTLER G.U.M. WITH FLUORIDE | JES | 1995-06-28 | 56 |
| K950993 | BUTLER G.U.M. ANTIBACTERIAL TOOTHBRUSH | EFW | 1995-06-02 | 91 |
| K943942 | TRAV-LER KIT | JEQ | 1995-03-08 | 208 |
| K874194 | PROTECT DROPS/SAME AS K874070 | EJK | 1987-12-16 | 63 |
Recalls
openFDA lists no recalls under a recalling firm named John O. Butler 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 John O. Butler Co. have?
John O. Butler Co. has 6 FDA 510(k) clearances (first 1987, latest 2002), across 4 product codes in 1 review panel.
How long does FDA take to clear John O. Butler Co.'s 510(k)s?
The median time from FDA receipt to decision across John O. Butler Co.'s cleared 510(k)s is 82 days.
What devices does John O. Butler Co. make?
Its most frequent FDA product codes are EFW (Toothbrush, Manual, 2); JEQ (Toothbrush, Powered, 2); EJK (Liner, Cavity, Calcium Hydroxide, 1).
Has John O. Butler Co. had device recalls?
openFDA lists no recalls under a recalling firm name matching John O. Butler Co. Related entities may recall under other names.
Next steps
- See all 6 John O. Butler Co. clearances with predicates and recalls
- Run predicate analysis for product code EFW, John O. Butler 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.