Personal Products Co.: FDA filings under this applicant name
FDA lists 45 510(k) clearances under the applicant name “Personal Products Co.” (first 1976, latest 2007), across 10 product codes in 4 review panels. Median 510(k) review time under this name: 61 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 |
|---|---|---|---|
| HEB | Tampon, Menstrual, Unscented | 14 | 14 |
| HHD | Pad, Menstrual, Unscented | 12 | 12 |
| HHL | Pad, Menstrual, Scented, Scented-Deodorized | 6 | 6 |
| HIL | Tampon, Menstrual, Scented, Scented-Deodorized | 6 | 6 |
| NUC | Lubricant, Personal | 2 | 2 |
| EFW | Toothbrush, Manual | 1 | 1 |
| HAD | Rongeur, Powered | 1 | 1 |
| HHI | System, Abortion, Vacuum | 1 | 1 |
| MNG | External Urethral Occluder, Urinary Incontinence-Control, Female | 1 | 1 |
Plus 1 more product codes.
Review panels
- Obstetrics and Gynecology (41)
- Dental (1)
- Gastroenterology and Urology (1)
- Neurology (1)
Most recent Personal Products Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K070545 | K-Y BRAND WARMING LIQUID | NUC | 2007-03-23 | 25 |
| K062796 | K-Y BRAND INTRIGUE | NUC | 2006-12-08 | 80 |
| K010365 | ORTHO CONTROL FEMALE URINARY CONTROL DEVICE | MNG | 2001-04-30 | 82 |
| K990536 | O.B. TAMPON | HEB | 1999-08-31 | 193 |
| K991118 | O.B. APPLICATOR TAMPONS, O.B. TAMPONS | HEB | 1999-06-29 | 89 |
| K974629 | O.B. APPLICATOR AND NON-APPLICATOR TAMPONS | HEB | 1998-02-10 | 60 |
| K971589 | REACH ANTIBACTERIAL TOOTHBRUSH | EFW | 1997-07-24 | 84 |
| K970954 | O.B. APPLICATOR TAMPONS | HEB | 1997-06-10 | 85 |
| K961119 | CAREFREE PANTYLINERS | HHL | 1996-04-17 | 27 |
| K953638 | O.B. APPLICATOR TAMPONS | HIL | 1995-10-20 | 77 |
35 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Personal Products 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.
- Personal Products Co., Div. of Mcneil Ppc, Inc. (2 510(k)s)
- Personal Products Company, Div. of Mcneil-Ppc, Inc. (2 510(k)s)
- Personal Sound Technologies, Inc. (2 510(k)s)
- Personal Genome Diagnostics, Inc. (1 510(k)s)
- Personal Computers For Medicine, Inc. (1 510(k)s)
- Personal Emergency Response System (1 510(k)s)
- Personal Health Institute International (1 510(k)s)
- Personal Professional Products, Inc. (1 510(k)s)
- Personal Health & Hygiene, Inc. (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Personal Products Co.?
FDA lists 45 510(k) clearances under the applicant name “Personal Products Co.” (first 1976, latest 2007), across 10 product codes in 4 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 Personal Products Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Personal Products Co. is 61 days.
Which FDA product codes appear under Personal Products Co.?
The most frequent FDA product codes under this applicant name are HEB (Tampon, Menstrual, Unscented, 14); HHD (Pad, Menstrual, Unscented, 12); HHL (Pad, Menstrual, Scented, Scented-Deodorized, 6).
Next steps
- See all 45 Personal Products Co. clearances with predicates and recalls
- Run predicate analysis for product code HEB, Personal Products 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.