Data / Medical devices / United States / Su-Ko Technologies LLC
Su-Ko Technologies LLC: FDA-registered device maker in Austin, TX, United States, 2 510(k) clearances
Su-Ko Technologies LLC is registered with the FDA (registration 3035372180) in Austin, TX, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated October 29, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3035372180
- Address
- 7801 N Lamar Blvd Ste F34, Austin, TX, United States, 78752
- Owner or operator
- Su-Ko Technologies LLC (10092391)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- May 16, 2025
- Registered through
- 2027
- Brand names listed
- MD Pen, SER Pen Carain Microsystem (MP1209SP), mdpen
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Microneedle Device | QAI | 2 | Complaint file establishment, Specification developer | 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 |
|---|---|---|---|---|---|---|
| October 29, 2025 | K253153 | SER Pen Carain MicroSystem (MP1209SP) | QAI | Substantially Equivalent | Su-Ko Technologies, LLC | accessdata.fda.gov |
| October 9, 2024 | K241355 | SER Pen Carain MicroSystem (MP1209SP) | QAI | Substantially Equivalent | Su-Ko Technologies, LLC | accessdata.fda.gov |
Compare with other makers
Updated October 29, 2025. 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.