Data / Medical devices / United States / Molekule Group, Inc.
Molekule Group, Inc.: FDA-registered device maker in Lakeland, FL, United States, 3 510(k) clearances
Molekule Group, Inc. is registered with the FDA (registration 3019585201) in Lakeland, FL, United States. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated August 20, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3019585201
- Address
- 4000 N. Combee Rd., Lakeland, FL, United States, 33805
- Owner or operator
- Molekule Group, Inc. (10072687)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- April 30, 2020
- Registered through
- 2026
- Brand names listed
- Air Pro RX, Molekule Air Mini, Molekule Air Mini +, Molekule Air Pro
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Purifier, Air, Ultraviolet, Medical | FRA | 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 |
|---|---|---|---|---|---|---|
| August 20, 2021 | K211194 | Molekule Air Pro | FRA | Substantially Equivalent | Molekule, Inc. | accessdata.fda.gov |
| February 23, 2021 | K202339 | Molekule Air Mini, Molekule Air Mini + | FRA | Substantially Equivalent | Molekule, Inc. | accessdata.fda.gov |
| April 15, 2020 | K200500 | Molekule Air Pro RX | FRA | Substantially Equivalent | Molekule, Inc. | accessdata.fda.gov |
Compare with other makers
Updated August 20, 2021. 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.