Windmere Corp.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Windmere Corp.” (first 1990, latest 1998), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 173 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 |
|---|---|---|---|
| IRO | Vibrator, Therapeutic | 3 | 3 |
| ISA | Massager, Therapeutic, Electric | 2 | 2 |
| ILJ | Bath, Hydro-Massage | 1 | 1 |
| JEQ | Toothbrush, Powered | 1 | 1 |
Review panels
- Physical Medicine (6)
- Dental (1)
Most recent Windmere Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K980769 | WINDMERE MODEL DS-2 FOOT BATH | ILJ | 1998-03-27 | 28 |
| K932904 | WINDMERE WAND MASSAGER | ISA | 1994-02-17 | 246 |
| K933974 | WINDMERE MASSAGE MATE | IRO | 1994-02-02 | 173 |
| K924237 | WINDMERE PRELUDE III | ISA | 1993-10-18 | 420 |
| K931086 | WINDMERE VIBRA TOUCH PERSONAL BODY MASSAGER | IRO | 1993-09-30 | 211 |
| K912659 | SOUND RELIEF | IRO | 1991-09-06 | 81 |
| K896245 | PLAK TRAC POWERED TOOTHBRUSH | JEQ | 1990-03-28 | 149 |
Recalls
openFDA lists no recalls under a recalling firm named Windmere Corp..
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 Windmere Corp.?
FDA lists 7 510(k) clearances under the applicant name “Windmere Corp.” (first 1990, latest 1998), across 4 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 Windmere Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Windmere Corp. is 173 days.
Which FDA product codes appear under Windmere Corp.?
The most frequent FDA product codes under this applicant name are IRO (Vibrator, Therapeutic, 3); ISA (Massager, Therapeutic, Electric, 2); ILJ (Bath, Hydro-Massage, 1).
Next steps
- See all 7 Windmere Corp. clearances with predicates and recalls
- Run predicate analysis for product code IRO, Windmere Corp.'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.