Data / Medical devices / United States / Benchmark Medical Instruments
Benchmark Medical Instruments: FDA-registered device maker in Sayreville, NJ, United States, 3 510(k) clearances
Benchmark Medical Instruments is registered with the FDA (registration 3011877754) in Sayreville, NJ, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 28, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011877754
- Address
- 2600 Main St, Sayreville, NJ, United States, 08872
- Owner or operator
- Benchmark Medical Instruments (10096198)
- Roles
- Repackager or relabeler
- First device listed
- July 22, 2026
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Indicator, Physical/Chemical Sterilization Process | JOJ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Sterilizer, Steam | FLE | 2 | Repackager or relabeler | accessdata.fda.gov |
| Wrap, Sterilization | FRG | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 28, 2026 | K251347 | Sterilization Pouch/Roll | FRG | Substantially Equivalent | Sterivic Medical Co., Ltd. | accessdata.fda.gov |
| June 6, 2025 | K243994 | Steam Sterilizer (2545D) | FLE | Substantially Equivalent | Ningbo Ican Machines Co., Ltd. | accessdata.fda.gov |
| March 10, 2022 | K220133 | Sterilization Wraps | FRG | Substantially Equivalent | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Wrap, Sterilization
- All makers of Indicator, Physical/Chemical Sterilization Process
- All makers of Sterilizer, Steam
Updated January 28, 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.