STERIS: FDA 510(k) clearances across all its applicant names
FDA lists 450 510(k) clearances, 0 PMA and 4 De Novo decisions across the 16 applicant names Caduvo groups under STERIS, first 1977, latest 2026. Median 510(k) review time across these names: 89 days. Since 2017 the median was 76 days, against 126 days for all cleared 510(k)s in the same product codes. Groups are curated by Caduvo from public sources listed below; FDA does not group applicants. Counts include filings made before an acquisition, and can include older filings by a business that was later sold when FDA records them under the same applicant name; see the notes on this page.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 10 | 128 |
| 2013 | 6 | 141 |
| 2014 | 12 | 140 |
| 2015 | 7 | 85 |
| 2016 | 9 | 141 |
| 2017 | 16 | 107 |
| 2018 | 33 | 96 |
| 2019 | 23 | 54 |
| 2020 | 10 | 46 |
| 2021 | 11 | 103 |
| 2022 | 14 | 28 |
| 2023 | 26 | 76 |
| 2024 | 15 | 30 |
| 2025 | 9 | 29 |
| 2026 | 3 | 85 |
The 16 FDA applicant names in this group
| Applicant name | 510(k) clearances | PMA | De Novo | Years |
|---|---|---|---|---|
| STERIS Corporation | 223 | 0 | 4 | 1997–2026 |
| United States Endoscopy Group, Inc. | 94 | 0 | 0 | 1991–2020 |
| American Sterilizer Co. | 36 | 0 | 0 | 1977–1994 |
| Minntech Corp. | 33 | 0 | 0 | 1987–2012 |
| Amsco Co. | 19 | 0 | 0 | 1977–1992 |
| Medivators, Inc. | 13 | 0 | 0 | 1987–2023 |
| Amsco Sterile Recoveries, Inc. | 12 | 0 | 0 | 1992–1994 |
| Steris Corporations | 7 | 0 | 0 | 2018–2021 |
| Medivators (A Subsidiary of Steris Corporation) | 3 | 0 | 0 | 2023–2024 |
| Medivators Reprocessing Systems | 3 | 0 | 0 | 2007–2011 |
| Steris Corparation | 2 | 0 | 0 | 2022–2025 |
| Amsco American Sterilizer Co. | 1 | 0 | 0 | 1994–1994 |
| Amsco Hospital Products Co. | 1 | 0 | 0 | 1977–1977 |
| Amsco Intl., Inc. | 1 | 0 | 0 | 1998–1998 |
| Steris C/O Medical Device Consultants, Inc. | 1 | 0 | 0 | 1988–1988 |
| United States Endoscopy Group, Inc. (Us Endoscopy) | 1 | 0 | 0 | 2018–2018 |
Review time against the same product codes
Since 2017, 510(k)s cleared under these names took a median 76 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 126 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JOJ | Indicator, Physical/Chemical Sterilization Process | 52 | 52 |
| FRC | Indicator, Biological Sterilization Process | 40 | 40 |
| FLE | Sterilizer, Steam | 26 | 26 |
| MED | Sterilant, Medical Devices | 25 | 25 |
| MLR | Sterilizer, Chemical | 20 | 20 |
| ODC | Endoscope Channel Accessory | 15 | 15 |
| FRG | Wrap, Sterilization | 14 | 14 |
| FEB | Accessories, Cleaning, For Endoscope | 13 | 13 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 12 | 12 |
| FDI | Snare, Flexible | 11 | 11 |
Plus 95 more product codes.
Review panels
- General Hospital (251)
- Gastroenterology and Urology (120)
- General and Plastic Surgery (53)
- Cardiovascular (12)
- Ear, Nose and Throat (4)
- Obstetrics and Gynecology (4)
- Orthopedic (3)
- Dental (2)
- Neurology (2)
- Microbiology (1)
- Physical Medicine (1)
Most recent STERIS 510(k) clearances
| 510(k) | Device | Applicant name | Product code | Decision date | Review days |
|---|---|---|---|---|---|
| K261055 | AMSCO 700 Steam Sterilizer | STERIS Corporation | FLE | 2026-06-24 | 85 |
| K260766 | Celerity 5 HP Biological Indicator (LCB052) | STERIS Corporation | 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 | STERIS Corporation | MED | 2026-04-08 | 313 |
| K252680 | Celerity 20 HP Biological Indicator | STERIS Corporation | 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) | STERIS Corporation | FRC | 2025-06-06 | 28 |
| K251048 | Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 | STERIS Corporation | JOJ | 2025-05-02 | 29 |
| K243876 | VERIFY STEAM Integrating Indicator | STERIS Corporation | JOJ | 2025-04-25 | 128 |
| K250842 | PADLOCK CLIP EFTR Kit (00713229) | STERIS Corporation | PKL | 2025-04-18 | 29 |
| K242773 | Electro Lube NXT | STERIS Corporation | GEI | 2025-04-15 | 214 |
| K250140 | Defendo Fujifilm 700 Single Use Cleaning Adapter | Steris Corparation | ODC | 2025-02-20 | 34 |
440 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
152 product recalls in 87 recall events under these names; 28 initiated in the last five years.
Recalling firms are matched to the applicant names above by name only, so recalls filed under other names are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
How this group is built
Groups are curated by Caduvo from public sources listed below; FDA does not group applicants. Counts include filings made before an acquisition, and can include older filings by a business that was later sold when FDA records them under the same applicant name; see the notes on this page.
Amsco/American Sterilizer (1996), US Endoscopy (2011), Cantel Medical incl. Medivators and Minntech (2021). Includes filings made before each acquisition. Left out: Cantel's dental businesses (Crosstex, Hu-Friedy) — STERIS sold its Dental segment to Peak Rock Capital in 2024.
Sources
- https://en.wikipedia.org/wiki/Steris
- https://www.hufriedygroup.com/en/news/peak-rock-capital-affiliate-signs-definitive-agreement-acquire-hufriedygroup
Frequently asked questions
How many FDA 510(k) clearances are listed across STERIS's applicant names?
FDA lists 450 510(k) clearances, 0 PMA and 4 De Novo decisions across the 16 applicant names Caduvo groups under STERIS, first 1977, latest 2026. FDA records each applicant name separately; Caduvo adds up the names listed on this page.
Which FDA applicant names does STERIS file under?
The names with the most 510(k) clearances in this group are STERIS Corporation (223); United States Endoscopy Group, Inc. (94); American Sterilizer Co. (36); Minntech Corp. (33); Amsco Co. (19). The full list of 16 names is on this page.
How long does FDA take to clear STERIS 510(k)s?
The median time from FDA receipt to decision across 510(k)s cleared under these names is 89 days. Since 2017 the median was 76 days, against 126 days for all cleared 510(k)s in the same product codes.
Does the STERIS count include acquired companies?
Yes. A group includes filings an acquired business made under its own name, including before the acquisition. Businesses that were sold are left out, and names whose ownership is unclear are not included. FDA does not group applicants; the sources for each grouping are listed on this page.
Next steps
- See all 450 STERIS clearances with predicates and recalls
- Run predicate analysis for product code JOJ, STERIS's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls). Applicant names are matched exactly, with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this grouping or data.
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