Procter & Gamble Co.: FDA clearances and approvals
Procter & Gamble Co. has 26 FDA 510(k) clearances (first 1988, latest 2015), across 9 product codes in 2 review panels. Median 510(k) review time: 77 days. It files with the SEC as PROCTER & GAMBLE Co (PG).
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 22 |
| 2014 | 1 | 147 |
| 2015 | 1 | 205 |
| 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 |
|---|---|---|---|
| HEB | Tampon, Menstrual, Unscented | 7 | 7 |
| HHD | Pad, Menstrual, Unscented | 6 | 6 |
| HIL | Tampon, Menstrual, Scented, Scented-Deodorized | 4 | 4 |
| HHL | Pad, Menstrual, Scented, Scented-Deodorized | 3 | 3 |
| EFW | Toothbrush, Manual | 2 | 2 |
| HHW | Pessary, Vaginal | 1 | 1 |
| JEQ | Toothbrush, Powered | 1 | 1 |
| JES | Floss, Dental | 1 | 1 |
| KOO | Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt | 1 | 1 |
Review panels
- Obstetrics and Gynecology (21)
- Dental (5)
Most recent Procter & Gamble Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K151413 | Always/Tampax bladder supports | HHW | 2015-12-18 | 205 |
| K141018 | ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBRUSH KIT, ORAL-B TEST DRIVE REFILL KIT | JEQ | 2014-09-15 | 147 |
| K131543 | TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED | HEB | 2013-06-20 | 22 |
| K091281 | TAMPAX PEARL UNSCENTED TAMPONS, LIGHT, REGULAR, SUPER & SUPER PLUS, TAMPAX PEARL UNSCENTED TAMPONS, ULTRA | HEB | 2010-06-01 | 396 |
| K091964 | CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS | JES | 2009-09-24 | 85 |
| K081555 | TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED | HIL | 2008-06-27 | 24 |
| K073224 | ORAL-B SUB-BRAND MANUAL TOOTHBRUSH | EFW | 2008-02-06 | 83 |
| K071827 | ALWAYS MENSTRUAL PADS | HHD | 2007-09-20 | 79 |
| K062638 | TAMPAX COMPAK PEARL PLASTIC APPLICATOR SCENTED AND UNSCENTED TAMPONS | HEB | 2006-11-22 | 78 |
| K061486 | TAMPAX TAMPONS - (LIGHT,REGULAR,SUPER AND SUPER PLUS ABSORBENCIES) | HEB | 2006-08-01 | 62 |
16 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Procter & Gamble 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.
SEC filings
PROCTER & GAMBLE Co (PG): EDGAR filings, CIK 80424. Matched by exact company name.
Frequently asked questions
How many FDA 510(k) clearances does Procter & Gamble Co. have?
Procter & Gamble Co. has 26 FDA 510(k) clearances (first 1988, latest 2015), across 9 product codes in 2 review panels.
How long does FDA take to clear Procter & Gamble Co.'s 510(k)s?
The median time from FDA receipt to decision across Procter & Gamble Co.'s cleared 510(k)s is 77 days.
What devices does Procter & Gamble Co. make?
Its most frequent FDA product codes are HEB (Tampon, Menstrual, Unscented, 7); HHD (Pad, Menstrual, Unscented, 6); HIL (Tampon, Menstrual, Scented, Scented-Deodorized, 4).
Has Procter & Gamble Co. had device recalls?
openFDA lists no recalls under a recalling firm name matching Procter & Gamble Co. Related entities may recall under other names.
Next steps
- See all 26 Procter & Gamble Co. clearances with predicates and recalls
- Run predicate analysis for product code HEB, Procter & Gamble 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.