The Procter & Gamble Company: FDA clearances and approvals
The Procter & Gamble Company has 5 FDA 510(k) clearances (first 2012, latest 2021), across 3 product codes in 2 review panels. Median 510(k) review time: 112 days. Since 2017 its median was 119 days, against 140 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 27 |
| 2013 | 0 | — |
| 2014 | 1 | 79 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 2 | 130 |
| 2021 | 1 | 119 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, The Procter & Gamble Company's cleared 510(k)s took a median 119 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 140 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HEB | Tampon, Menstrual, Unscented | 2 | 2 |
| LFD | Saliva, Artificial | 2 | 2 |
| JEQ | Toothbrush, Powered | 1 | 1 |
Review panels
- Dental (3)
- Obstetrics and Gynecology (2)
Most recent The Procter & Gamble Company 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K203567 | Oral-B Dry Mouth Oral Rinse | LFD | 2021-04-05 | 119 |
| K201277 | Oral-B Dry Mouth Oral Rinse | LFD | 2020-09-02 | 112 |
| K200881 | Oral-B iO Test Drive Power Brush Trial Program Kit | JEQ | 2020-08-27 | 147 |
| K133244 | TAMPAX M PLASTIC TAMPONS, UNSCENTED | HEB | 2014-01-09 | 79 |
| K113699 | TAMPAX(R) V PLASTIC APPLICATOR TAMPONS, UNSCENTED | HEB | 2012-01-12 | 27 |
Recalls
openFDA lists no recalls under a recalling firm named The Procter & Gamble Company.
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 The Procter & Gamble Company have?
The Procter & Gamble Company has 5 FDA 510(k) clearances (first 2012, latest 2021), across 3 product codes in 2 review panels.
How long does FDA take to clear The Procter & Gamble Company's 510(k)s?
The median time from FDA receipt to decision across The Procter & Gamble Company's cleared 510(k)s is 112 days. Since 2017: 119 days, versus 140 days for all cleared 510(k)s in the same product codes.
What devices does The Procter & Gamble Company make?
Its most frequent FDA product codes are HEB (Tampon, Menstrual, Unscented, 2); LFD (Saliva, Artificial, 2); JEQ (Toothbrush, Powered, 1).
Has The Procter & Gamble Company had device recalls?
openFDA lists no recalls under a recalling firm name matching The Procter & Gamble Company. Related entities may recall under other names.
Next steps
- See all 5 The Procter & Gamble Company clearances with predicates and recalls
- Run predicate analysis for product code HEB, The Procter & Gamble Company'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.