Procter & Gamble Mfg. Co.: FDA filings under this applicant name
FDA lists 72 510(k) clearances under the applicant name “Procter & Gamble Mfg. Co.” (first 1976, latest 1988), across 20 product codes in 5 review panels. Median 510(k) review time under this name: 25 days. 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 | 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 |
|---|---|---|---|
| KKX | Drape, Surgical, Antimicrobial | 14 | 14 |
| HHD | Pad, Menstrual, Unscented | 11 | 11 |
| HHL | Pad, Menstrual, Scented, Scented-Deodorized | 10 | 10 |
| EYQ | Garment, Protective, For Incontinence | 6 | 6 |
| FYA | Gown, Surgical | 5 | 5 |
| HIL | Tampon, Menstrual, Scented, Scented-Deodorized | 4 | 4 |
| KME | Bedding, Disposable, Medical | 3 | 3 |
| FXP | Cover, Shoe, Operating-Room | 2 | 2 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | 2 | 2 |
| HEB | Tampon, Menstrual, Unscented | 2 | 2 |
Plus 10 more product codes.
Review panels
- Obstetrics and Gynecology (28)
- General Hospital (27)
- Gastroenterology and Urology (6)
- General and Plastic Surgery (6)
- Pathology (1)
Most recent Procter & Gamble Mfg. Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K873457 | SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS | HIL | 1988-01-19 | 144 |
| K873036 | ATTENDS INCONTINENT BRIEF | EYQ | 1988-01-19 | 168 |
| K864673 | UNSCENTED MENSTRUAL PAD | HHL | 1987-01-21 | 50 |
| K861863 | MODIFIED PROTECTIVE GARMENT | EYQ | 1986-08-11 | 88 |
| K862348 | SINGLE-USE PATIENT UNDERPAD | KME | 1986-07-02 | 12 |
| K860598 | MODIFIED PROTECTIVE GARMENT FOR INCONTINENTS | EYQ | 1986-03-05 | 14 |
| K853880 | ATTENDS DISPOS. UNDERPAD | KME | 1985-10-16 | 28 |
| K853000 | SCENTED ALWAYS PANTILINERS | HHL | 1985-09-06 | 53 |
| K852985 | UNSCENTED ALWAYS PANTILINERS | HHD | 1985-08-29 | 45 |
| K850956 | ALWAYS MAXIPADS - SCENTED | HHL | 1985-05-14 | 67 |
62 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Procter & Gamble Mfg. 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.
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 Co. (26 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Procter & Gamble Mfg. Co.?
FDA lists 72 510(k) clearances under the applicant name “Procter & Gamble Mfg. Co.” (first 1976, latest 1988), across 20 product codes in 5 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 Mfg. Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Procter & Gamble Mfg. Co. is 25 days.
Which FDA product codes appear under Procter & Gamble Mfg. Co.?
The most frequent FDA product codes under this applicant name are KKX (Drape, Surgical, Antimicrobial, 14); HHD (Pad, Menstrual, Unscented, 11); HHL (Pad, Menstrual, Scented, Scented-Deodorized, 10).
Next steps
- See all 72 Procter & Gamble Mfg. Co. clearances with predicates and recalls
- Run predicate analysis for product code KKX, Procter & Gamble Mfg. 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.