Mcneil-Ppc, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Mcneil-Ppc, Inc.” (first 2002, latest 2008), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 130 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 |
|---|---|---|---|
| NUC | Lubricant, Personal | 5 | 5 |
| HEB | Tampon, Menstrual, Unscented | 1 | 1 |
Review panels
Most recent Mcneil-Ppc, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K081236 | K-Y BRAND INTRIGUE 2-IN-1 MASSAGE CREME | NUC | 2008-09-25 | 147 |
| K072421 | K-Y BRAND YOURS+MINE | NUC | 2008-03-06 | 191 |
| K072360 | K-Y BRAND INTRIGUE INTENSE WARMING SENSATION | NUC | 2007-12-12 | 112 |
| K062535 | K-Y BRAND TOUCH MASSAGE 2-IN-1 TINGLING | NUC | 2007-01-26 | 150 |
| K053397 | K-Y BRAND SENSUAL MIST | NUC | 2006-02-17 | 73 |
| K023789 | O.B. TAMPONS | HEB | 2002-12-06 | 23 |
Recalls
openFDA lists no recalls under a recalling firm named Mcneil-Ppc, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Mcneil-Ppc, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Mcneil-Ppc, Inc.” (first 2002, latest 2008), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Mcneil-Ppc, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mcneil-Ppc, Inc. is 130 days.
Which FDA product codes appear under Mcneil-Ppc, Inc.?
The most frequent FDA product codes under this applicant name are NUC (Lubricant, Personal, 5); HEB (Tampon, Menstrual, Unscented, 1).
Next steps
- See all 6 Mcneil-Ppc, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NUC, Mcneil-Ppc, Inc.'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.