Cleerly, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Cleerly, Inc.” (first 2019, latest 2026), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 141 days. Since 2017 the median was 141 days, against 131 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 1 | 216 |
| 2020 | 1 | 52 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 123 |
| 2024 | 0 | — |
| 2025 | 1 | 212 |
| 2026 | 2 | 132 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Cleerly, Inc. took a median 141 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 131 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 3 | 3 |
| QIH | Automated Radiological Image Processing Software | 2 | 2 |
| QXZ | Adjunctive Epicardial Vascular Physiologic Status Indicator | 1 | 1 |
Review panels
- Radiology (5)
- Cardiovascular (1)
Most recent Cleerly, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261210 | Cleerly Plaque | QIH | 2026-07-29 | 106 |
| K260588 | Cleerly LABS | LLZ | 2026-07-29 | 159 |
| K242338 | Cleerly LABS (v2.0) | QIH | 2025-03-07 | 212 |
| K231335 | Cleerly ISCHEMIA | QXZ | 2023-09-08 | 123 |
| K202280 | Cleerly Labs v2.0 | LLZ | 2020-10-02 | 52 |
| K190868 | Cleerly Labs | LLZ | 2019-11-05 | 216 |
Recalls
openFDA lists no recalls under a recalling firm named Cleerly, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Cleerly, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT06713239: A Randomized Comparison of Personalized Therapy Mgmt Based On Coronary Atherosclerotic Plaque Vs. Usual Care for Symptomatic Patients With Suspicion of CAD (Recruiting, started 2024-12-18)
- NCT06112418: A Randomized Comparison of Stage-Based Care Versus Risk Factor-Based Care for Prevention of Cardiovascular Events (Recruiting, started 2024-03-06)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cleerly, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Cleerly, Inc.” (first 2019, latest 2026), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Cleerly, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cleerly, Inc. is 141 days. Since 2017: 141 days, versus 131 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Cleerly, Inc.?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 3); QIH (Automated Radiological Image Processing Software, 2); QXZ (Adjunctive Epicardial Vascular Physiologic Status Indicator, 1).
Next steps
- See all 6 Cleerly, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Cleerly, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.