Data / Medical devices / Sterilizer, Chemical
Sterilizer, Chemical (MLR): 12 FDA-registered makers in 6 countries
12 establishments in 6 countries are registered with the FDA to make Sterilizer, Chemical (product code MLR, Class 2, 21 CFR 880.6860). 7 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 47 510(k) clearances under this code, the latest on April 15, 2026, and lists 33 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MLR
- Device class
- 2
- Regulation
- 880.6860
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| South Korea | 2 |
| Mexico | 1 |
| Switzerland | 1 |
| China | 1 |
| Canada | 1 |
Makers of Sterilizer, Chemical
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| STERIS Corporation | Mentor, OH, United States | Manufacturer | 20 | October 20, 2023 | 0 | 0 | 0 | api.fda.gov |
| STERIS MEXICO, S. de R.L. de C.V. | GUADALUPE Nuevo Leon, Mexico | Complaint file establishment, Manufacturer | 20 | October 20, 2023 | 0 | 0 | 0 | api.fda.gov |
| Steris Corporation | Mentor, OH, United States | Specification developer | 19 | October 20, 2023 | 0 | 10 | 0 | api.fda.gov |
| Advanced Sterilization Products | Irvine, CA, United States | Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer | 11 | July 5, 2024 | 0 | 23 | 0 | api.fda.gov |
| ASP Global Manufacturing GmbH | Schaffhausen, Switzerland | Manufacturer | 8 | September 27, 2016 | 0 | 0 | 0 | api.fda.gov |
| Plasmapp Co., Ltd. | Seongnam-si Gyeonggi, South Korea | Manufacturer, Repackager or relabeler | 4 | May 25, 2023 | 0 | 0 | 0 | api.fda.gov |
| Ideate Medical | Saint Louis, MO, United States | Complaint file establishment, Specification developer | 1 | June 27, 2024 | 0 | 0 | 0 | api.fda.gov |
| Dreamtech Co., Ltd. | Asan-si Chungnam, South Korea | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Inc. | Auburn Hills, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Incote Precision Machinery Co., Ltd. | Ningbo City Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STERIS Canada ULC | Quebec, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zimmer, Inc. | Warsaw, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 15, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.