STERIS Corporation: FDA clearances and approvals
STERIS Corporation has 223 FDA 510(k) clearances (first 1997, latest 2026), plus 4 De Novo decisions, across 37 product codes in 5 review panels. Median 510(k) review time: 89 days. Since 2017 its median was 84 days, against 122 days for all cleared 510(k)s in the same product codes. openFDA lists 142 product recalls by a recalling firm named STERIS Corporation.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 5 | 117 |
| 2013 | 4 | 145 |
| 2014 | 6 | 142 |
| 2015 | 1 | 145 |
| 2016 | 6 | 126 |
| 2017 | 12 | 132 |
| 2018 | 26 | 102 |
| 2019 | 18 | 78 |
| 2020 | 8 | 46 |
| 2021 | 10 | 104 |
| 2022 | 12 | 28 |
| 2023 | 23 | 75 |
| 2024 | 13 | 30 |
| 2025 | 8 | 29 |
| 2026 | 3 | 85 |
Review time against the same product codes
Since 2017, STERIS Corporation's cleared 510(k)s took a median 84 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 122 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JOJ | Indicator, Physical/Chemical Sterilization Process | 42 | 42 |
| FRC | Indicator, Biological Sterilization Process | 35 | 35 |
| FLE | Sterilizer, Steam | 23 | 23 |
| MLR | Sterilizer, Chemical | 20 | 20 |
| MED | Sterilant, Medical Devices | 19 | 19 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 11 | 11 |
| NZA | Accessories, Germicide, Cleaning, For Endoscopes | 9 | 9 |
| FRG | Wrap, Sterilization | 8 | 8 |
| ODC | Endoscope Channel Accessory | 7 | 7 |
| NVE | Washer, Cleaner, Automated, Endoscope | 5 | 5 |
Plus 27 more product codes.
Review panels
- General Hospital (194)
- Gastroenterology and Urology (20)
- General and Plastic Surgery (11)
- Cardiovascular (1)
- Physical Medicine (1)
Most recent STERIS Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261055 | AMSCO 700 Steam Sterilizer | FLE | 2026-06-24 | 85 |
| K260766 | Celerity 5 HP Biological Indicator (LCB052) | FRC | 2026-04-08 | 30 |
| K251666 | SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 | MED | 2026-04-08 | 313 |
| K252680 | Celerity 20 HP Biological Indicator | FRC | 2025-09-24 | 30 |
| K251452 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) | FRC | 2025-06-06 | 28 |
| K251048 | Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 | JOJ | 2025-05-02 | 29 |
| K243876 | VERIFY STEAM Integrating Indicator | JOJ | 2025-04-25 | 128 |
| K250842 | PADLOCK CLIP EFTR Kit (00713229) | PKL | 2025-04-18 | 29 |
| K242773 | Electro Lube NXT | GEI | 2025-04-15 | 214 |
| K250061 | Celerity Incubator | FRC | 2025-02-06 | 27 |
213 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN240075 | De Novo | Interim Reprocessing Cleaning And Intermediate-Level Disinfection Wipe | 2026-05-01 |
| DEN230085 | De Novo | Qualitative Cleaning Process Protein Indicator | 2024-11-12 |
| DEN110006 | De Novo | Biological Sterilization Process Indicator With Recombinant-Dna Plasmid | 2013-07-12 |
| DEN110002 | De Novo | Liquid Chemical Processing System | 2012-03-30 |
Recalls
142 product recalls in 83 recall events; 28 initiated in the last five years. Most recent: 2026-05-15.
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 STERIS Corporation have?
STERIS Corporation has 223 FDA 510(k) clearances (first 1997, latest 2026), plus 4 De Novo decisions, across 37 product codes in 5 review panels.
How long does FDA take to clear STERIS Corporation's 510(k)s?
The median time from FDA receipt to decision across STERIS Corporation's cleared 510(k)s is 89 days. Since 2017: 84 days, versus 122 days for all cleared 510(k)s in the same product codes.
What devices does STERIS Corporation make?
Its most frequent FDA product codes are JOJ (Indicator, Physical/Chemical Sterilization Process, 42); FRC (Indicator, Biological Sterilization Process, 35); FLE (Sterilizer, Steam, 23).
Has STERIS Corporation had device recalls?
openFDA lists 142 product recalls in 83 recall events by a recalling firm whose name matches STERIS Corporation; the most recent began 2026-05-15. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 223 STERIS Corporation clearances with predicates and recalls
- Run predicate analysis for product code JOJ, STERIS Corporation'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.