Hamilton Industries, Inc.: FDA clearances and approvals
Hamilton Industries, Inc. has 5 FDA 510(k) clearances (first 1977, latest 1988), across 5 product codes in 3 review panels. Median 510(k) review time: 36 days.
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 |
|---|---|---|---|
| FNM | Mattress, Air Flotation, Alternating Pressure | 1 | 1 |
| INK | Stretcher, Wheeled, Powered | 1 | 1 |
| JOW | Sleeve, Limb, Compressible | 1 | 1 |
| LGX | Table, Examination, Medical, Powered | 1 | 1 |
Plus 1 more product codes.
Review panels
- General Hospital (2)
- Cardiovascular (1)
- Physical Medicine (1)
Most recent Hamilton Industries, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K883680 | MEDALIST EXAMINATION TABLE | LGX | 1988-10-04 | 36 |
| K792001 | COMFICARE PAD (FOR SINGEL PT USE) | FNM | 1979-10-26 | 21 |
| K790871 | ENCLOSED CASE CART | — | 1979-05-14 | 7 |
| K770956 | PAS ANTI-EMBOLISM SYSTEM | JOW | 1977-09-12 | 108 |
| K771018 | TRANS 2000 | INK | 1977-07-14 | 38 |
Recalls
openFDA lists no recalls under a recalling firm named Hamilton Industries, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Hamilton Industries, Inc. have?
Hamilton Industries, Inc. has 5 FDA 510(k) clearances (first 1977, latest 1988), across 5 product codes in 3 review panels.
How long does FDA take to clear Hamilton Industries, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Hamilton Industries, Inc.'s cleared 510(k)s is 36 days.
What devices does Hamilton Industries, Inc. make?
Its most frequent FDA product codes are FNM (Mattress, Air Flotation, Alternating Pressure, 1); INK (Stretcher, Wheeled, Powered, 1); JOW (Sleeve, Limb, Compressible, 1).
Has Hamilton Industries, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Hamilton Industries, Inc. Related entities may recall under other names.
Next steps
- See all 5 Hamilton Industries, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FNM, Hamilton Industries, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.