Steridyne Corp.: FDA clearances and approvals
Steridyne Corp. has 6 FDA 510(k) clearances (first 1980, latest 1993), across 5 product codes in 3 review panels. Median 510(k) review time: 34 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 |
|---|---|---|---|
| KIC | Cushion, Flotation | 2 | 2 |
| DXQ | Blood Pressure Cuff | 1 | 1 |
| FLK | Thermometer, Clinical Mercury | 1 | 1 |
| FQM | Bandage, Elastic | 1 | 1 |
| KDP | Regulator, Vacuum | 1 | 1 |
Review panels
- General Hospital (3)
- Physical Medicine (2)
- Cardiovascular (1)
Most recent Steridyne Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K925352 | CLEAN CUFF BLOOD PRESSURE CUFF LINER | DXQ | 1993-01-12 | 82 |
| K911843 | ZERO-G(TM) GEL/FOAM MATTRESS TOPPER | KIC | 1991-05-30 | 35 |
| K911269 | MERCURY AND GLASS FEVER THERMOMETER | FLK | 1991-05-15 | 54 |
| K842120 | ZERO-G | KIC | 1984-06-08 | 10 |
| K821314 | FEVER METER | KDP | 1982-05-28 | 24 |
| K801458 | WINTER HEAD DRESSING | FQM | 1980-07-28 | 34 |
Recalls
openFDA lists no recalls under a recalling firm named Steridyne Corp..
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 Steridyne Corp. have?
Steridyne Corp. has 6 FDA 510(k) clearances (first 1980, latest 1993), across 5 product codes in 3 review panels.
How long does FDA take to clear Steridyne Corp.'s 510(k)s?
The median time from FDA receipt to decision across Steridyne Corp.'s cleared 510(k)s is 34 days.
What devices does Steridyne Corp. make?
Its most frequent FDA product codes are KIC (Cushion, Flotation, 2); DXQ (Blood Pressure Cuff, 1); FLK (Thermometer, Clinical Mercury, 1).
Has Steridyne Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Steridyne Corp. Related entities may recall under other names.
Next steps
- See all 6 Steridyne Corp. clearances with predicates and recalls
- Run predicate analysis for product code KIC, Steridyne Corp.'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.