Steris Corporations: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Steris Corporations” (first 2018, latest 2021), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 38 days. Since 2017 the median was 38 days, against 106 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under STERIS, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 3 | 56 |
| 2019 | 3 | 38 |
| 2020 | 0 | — |
| 2021 | 1 | 28 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Steris Corporations took a median 38 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 106 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FRC | Indicator, Biological Sterilization Process | 3 | 3 |
| MED | Sterilant, Medical Devices | 2 | 2 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | 1 | 1 |
| ODC | Endoscope Channel Accessory | 1 | 1 |
Review panels
Most recent Steris Corporations 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K203630 | BioGuard Air/Water and Suction Valves | ODC | 2021-01-08 | 28 |
| K190104 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System | MED | 2019-03-22 | 59 |
| K183295 | Celerity HP Chemical Indicator (CI) | JOJ | 2019-01-04 | 38 |
| K183300 | VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack | FRC | 2019-01-03 | 37 |
| K182931 | VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag | FRC | 2018-11-20 | 29 |
| K180342 | SYSTEM 1E Liquid Chemical Sterilant Processing System | MED | 2018-04-04 | 56 |
| K172748 | VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack | FRC | 2018-02-09 | 150 |
Recalls
openFDA lists no recalls under a recalling firm named Steris Corporations.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- STERIS Corporation (223 510(k)s)
- Steris Corparation (2 510(k)s)
- Steris C/O Medical Device Consultants, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Steris Corporations?
FDA lists 7 510(k) clearances under the applicant name “Steris Corporations” (first 2018, latest 2021), 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 Steris Corporations?
The median time from FDA receipt to decision across 510(k)s cleared under the name Steris Corporations is 38 days. Since 2017: 38 days, versus 106 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Steris Corporations?
The most frequent FDA product codes under this applicant name are FRC (Indicator, Biological Sterilization Process, 3); MED (Sterilant, Medical Devices, 2); JOJ (Indicator, Physical/Chemical Sterilization Process, 1).
Next steps
- See all 7 Steris Corporations clearances with predicates and recalls
- Run predicate analysis for product code FRC, Steris Corporations'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.