Data / Medical devices / United States / Delta Hi-Tech, Inc.
Delta Hi-Tech, Inc.: FDA-registered device maker in Fairfield, OH, United States, 5 510(k) clearances
Delta Hi-Tech, Inc. is registered with the FDA (registration 1721183) in Fairfield, OH, United States. It lists 4 device types. The FDA files 5 510(k) clearances under its listings, the newest dated March 12, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1721183
- FEI number
- 3001239292
- Address
- 8695 Seward Road, Fairfield, OH, United States, 45011
- Owner or operator
- DELTA HI-TECH, INC. (1721183)
- Roles
- Complaint file establishment
- First device listed
- August 31, 2015
- Registered through
- 2026
- Brand names listed
- Aimsco Lancet
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Disinfectant, Medical Devices | LRJ | 1 | Complaint file establishment | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Complaint file establishment | accessdata.fda.gov |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | 2 | Complaint file establishment | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| March 12, 2019 | K181447 | Safety insulin needle for single use | FMI | Substantially Equivalent | Berpu Medical Technology Co., Ltd. | accessdata.fda.gov |
| August 3, 2018 | K163578 | EasyTouch Safety Pen Needle | FMI | Substantially Equivalent | Mhc Medical Products, LLC | accessdata.fda.gov |
| December 23, 2011 | K112789 | EASY TOUCH | FMI | Substantially Equivalent | Mhc Medical Products, LLC | accessdata.fda.gov |
| September 2, 2010 | K102178 | EASY TOUCH | FMF | Substantially Equivalent | Mhc Medical Products | accessdata.fda.gov |
| July 9, 2009 | K091474 | EASY.TOUCH INSULIN SYRINGE | FMF | Substantially Equivalent | Masters Healthcare, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Syringe, Piston
- All makers of Disinfectant, Medical Devices
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Updated March 12, 2019. 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.