Cooper-Hewitt Electric Co.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Cooper-Hewitt Electric Co.” (first 1981, latest 1987), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 35 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 |
|---|---|---|---|
| KMG | Purifier, Water, Ultraviolet, Medical | 6 | 6 |
| FRA | Purifier, Air, Ultraviolet, Medical | 1 | 1 |
| FTC | Light, Ultraviolet, Dermatological | 1 | 1 |
Review panels
Most recent Cooper-Hewitt Electric Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K860132 | AIR CARE AIR SANITIZER | FRA | 1987-01-13 | 364 |
| K862608 | SPERTILITE PHOTOTHERAPY LAMP | FTC | 1986-08-06 | 29 |
| K813050 | AQUANOMICS, #MP4SF | KMG | 1981-12-02 | 35 |
| K813049 | AQUANOMICS, #HHU100 | KMG | 1981-12-02 | 35 |
| K813048 | AQUANOMICS, #MP2SF | KMG | 1981-12-02 | 35 |
| K813047 | AQUANOMICS, MINI 60L | KMG | 1981-12-02 | 35 |
| K813046 | AQUANOMICS, #HHU60 | KMG | 1981-12-02 | 35 |
| K813045 | AQUANOMICS, #SP36SF | KMG | 1981-12-02 | 35 |
Recalls
openFDA lists no recalls under a recalling firm named Cooper-Hewitt Electric 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Cooper-Hewitt Electric Co.?
FDA lists 8 510(k) clearances under the applicant name “Cooper-Hewitt Electric Co.” (first 1981, latest 1987), across 3 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 Cooper-Hewitt Electric Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cooper-Hewitt Electric Co. is 35 days.
Which FDA product codes appear under Cooper-Hewitt Electric Co.?
The most frequent FDA product codes under this applicant name are KMG (Purifier, Water, Ultraviolet, Medical, 6); FRA (Purifier, Air, Ultraviolet, Medical, 1); FTC (Light, Ultraviolet, Dermatological, 1).
Next steps
- See all 8 Cooper-Hewitt Electric Co. clearances with predicates and recalls
- Run predicate analysis for product code KMG, Cooper-Hewitt Electric 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.