Data / Medical devices / United States / Cleerly, Inc
Cleerly, Inc: FDA-registered device maker in Denver, CO, United States, 5 510(k) clearances
Cleerly, Inc is registered with the FDA (registration 3017167291) in Denver, CO, United States. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated July 29, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3017167291
- Address
- 1099 18th Street Suite 2860, Denver, CO, United States, 80202
- Owner or operator
- Cleerly, Inc (10076670)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- December 9, 2020
- Registered through
- 2027
- Brand names listed
- Cleerly Coronary; Cleerly Labs v2, Cleerly Ischemia, Cleerly LABS, Cleerly LABS (v2), Cleerly Plaque
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adjunctive Epicardial Vascular Physiologic Status Indicator | QXZ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Complaint file establishment, Manufacturer | 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 |
|---|---|---|---|---|---|---|
| July 29, 2026 | K261210 | Cleerly Plaque | QIH | Substantially Equivalent | Cleerly, Inc. | accessdata.fda.gov |
| July 29, 2026 | K260588 | Cleerly LABS | LLZ | Substantially Equivalent | Cleerly, Inc. | accessdata.fda.gov |
| March 7, 2025 | K242338 | Cleerly LABS (v2.0) | QIH | Substantially Equivalent | Cleerly, Inc. | accessdata.fda.gov |
| September 8, 2023 | K231335 | Cleerly ISCHEMIA | QXZ | Substantially Equivalent | Cleerly, Inc. | accessdata.fda.gov |
| October 2, 2020 | K202280 | Cleerly Labs v2.0 | LLZ | Substantially Equivalent | Cleerly, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of Automated Radiological Image Processing Software
Updated July 29, 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.