510(k) Report

FDA applicant

Cleerly, Inc.

Denver, CO6 decisions2019–20260 recalls

FDA records 6 decisions for Cleerly, Inc. (Denver, CO) from 2019 to 2026: 6 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and QIH (Automated Radiological Image Processing Software). Since 2016 its 510(k)s took a median of 159 days from receipt to decision, against 115 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 4 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Cleerly, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2019: 12020: 12023: 12025: 12026 (partial year): 2
2019high 2 (2026) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Cleerly, Inc. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cleerly, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological3decisions
  • QIHAutomated Radiological Image Processing Software2decisions
  • QXZAdjunctive Epicardial Vascular Physiologic Status Indicator1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 159 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 115 days; 2 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 4 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K202280Cleerly Labs v2.0Cleerly, Inc. · 20203cite it
  • K242338Cleerly LABS (v2.0)Cleerly, Inc. · 20252cite it
  • K190868Cleerly LabsCleerly, Inc. · 20192cite it

What has FDA decided for it lately?

  • K261210Cleerly PlaqueCleerly, Inc. · 2026
  • K260588Cleerly LABSCleerly, Inc. · 2026
  • K242338Cleerly LABS (v2.0)Cleerly, Inc. · 2025
  • K231335Cleerly ISCHEMIACleerly, Inc. · 2023
  • K202280Cleerly Labs v2.0Cleerly, Inc. · 2020
  • K190868Cleerly LabsCleerly, Inc. · 2019

All 6 as Cleerly, Inc. →