# Cleerly, Inc.

- Location (FDA's records): Denver, CO
- FDA decisions: 6 (2019–2026): 6 510(k) clearances
- Product codes: LLZ (3), QIH (2), QXZ (1)
- 510(k) review time since 2016: median 159 days, against 115 for FDA's reviews in the same codes and years (2 of 5 faster)
- Predicates its devices cite: 6 (4 its own); citations of its devices by later devices: 7 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ultromics Limited: 1 (https://510kreport.com/company/ultromics)
- Object Research Systems (Ors), Inc.: 1 (https://510kreport.com/company/object-research-systems-ors)

## Firms that cite its devices most
- Circle Cardiovascular Imaging, Inc.: 1 (https://510kreport.com/company/circle-cardiovascular-imaging)
- Careverse Technology Pte., Ltd.: 1 (https://510kreport.com/company/careverse-technology)
- Siemens Medical Solutions USA, Inc.: 1 (https://510kreport.com/company/siemens-medical-solutions-usa)

## Its most-cited devices
- K202280: Cleerly Labs v2.0 (2020), cited by 3
- K242338: Cleerly LABS (v2.0) (2025), cited by 2
- K190868: Cleerly Labs (2019), cited by 2

## Recent decisions
- K261210: Cleerly Plaque (Jul 29, 2026)
- K260588: Cleerly LABS (Jul 29, 2026)
- K242338: Cleerly LABS (v2.0) (Mar 7, 2025)
- K231335: Cleerly ISCHEMIA (Sep 8, 2023)
- K202280: Cleerly Labs v2.0 (Oct 2, 2020)
- K190868: Cleerly Labs (Nov 5, 2019)

Source page: https://510kreport.com/company/cleerly