Procter & Gamble Co.: FDA filings under this applicant name
FDA lists 33 510(k) clearances under 5 spellings of the applicant name “Procter & Gamble Co.” (first 1988, latest 2021), across 10 product codes in 2 review panels. Median 510(k) review time under this name: 79 days. Since 2017 the median was 119 days, against 149 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 27 |
| 2013 | 1 | 22 |
| 2014 | 2 | 113 |
| 2015 | 1 | 205 |
| 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, 510(k)s cleared under the name Procter & Gamble Co. 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 149 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HEB | Tampon, Menstrual, Unscented | 10 | 10 |
| HHD | Pad, Menstrual, Unscented | 6 | 6 |
| HIL | Tampon, Menstrual, Scented, Scented-Deodorized | 4 | 4 |
| HHL | Pad, Menstrual, Scented, Scented-Deodorized | 3 | 3 |
| LFD | Saliva, Artificial | 3 | 3 |
| EFW | Toothbrush, Manual | 2 | 2 |
| JEQ | Toothbrush, Powered | 2 | 2 |
| HHW | Pessary, Vaginal | 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 (24)
- Dental (9)
Most recent Procter & Gamble Co. 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 |
| 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 |
| K133244 | TAMPAX M PLASTIC TAMPONS, UNSCENTED | HEB | 2014-01-09 | 79 |
| K131543 | TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED | HEB | 2013-06-20 | 22 |
| K113699 | TAMPAX(R) V PLASTIC APPLICATOR TAMPONS, UNSCENTED | HEB | 2012-01-12 | 27 |
| K110669 | TAMPAX C PLASTIC TAMPONS, UNSCENTED | HEB | 2011-06-02 | 85 |
| K091281 | TAMPAX PEARL UNSCENTED TAMPONS, LIGHT, REGULAR, SUPER & SUPER PLUS, TAMPAX PEARL UNSCENTED TAMPONS, ULTRA | HEB | 2010-06-01 | 396 |
23 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 applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Procter & Gamble Co. is the lead sponsor of 32 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT05594004: A Meta-analysis Comparing Toothbrushes on Plaque Removal and Gingival Health (Completed, started 2022-04-01)
- NCT05178641: Overnight Pant Study for Children With Nocturnal Enuresis (Completed, started 2022-01-13)
- NCT04899440: Measuring Efficacy of an Oral-Irrigator After Three Weeks of Use (Completed, started 2021-06-03)
- NCT04913636: Assessing Effects of a Denture Gel on Gum Abrasions (Completed, started 2021-06-01)
- NCT04189081: Improvement of Dry Mouth Sufferers After Using an Experimental Dry Mouth Rinse Compared to a Water Control (Completed, started 2020-05-13)
SEC filings
PROCTER & GAMBLE Co (PG): EDGAR filings, CIK 80424. An SEC registrant with the same name, matched by name only.
FDA spellings included
FDA records this applicant under 5 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Procter & Gamble Co. (23)
- The Procter & Gamble Company (5)
- Procter & Gamble (2)
- The Procter & Gamble Co. (2)
- Procter & Gamble, Inc. (1)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Procter & Gamble Mfg. Co. (72 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Procter & Gamble Co.?
FDA lists 33 510(k) clearances under 5 spellings of the applicant name “Procter & Gamble Co.” (first 1988, latest 2021), across 10 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Procter & Gamble Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Procter & Gamble Co. is 79 days. Since 2017: 119 days, versus 149 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Procter & Gamble Co.?
The most frequent FDA product codes under this applicant name are HEB (Tampon, Menstrual, Unscented, 10); HHD (Pad, Menstrual, Unscented, 6); HIL (Tampon, Menstrual, Scented, Scented-Deodorized, 4).
Next steps
- See all 33 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. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.