510(k) Report

FDA applicant

Curemetrix, Inc.

San Diego, CA4 decisions2019–20260 recalls

FDA records 4 decisions for Curemetrix, Inc. (San Diego, CA) from 2019 to 2026: 4 510(k) clearances. Most are in product codes QIH (Automated Radiological Image Processing Software) and QFM (Radiological Computer-Assisted Prioritization…). Since 2016 its 510(k)s took a median of 80 days from receipt to decision, against 140 for FDA’s reviews in the same codes and years. Its devices cite 1 predicate, 0 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 Curemetrix, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2019: 12023: 12025: 12026 (partial year): 1
2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

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

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Which product codes does it file in?

  • QIHAutomated Radiological Image Processing Software3decisions
  • QFMRadiological Computer-Assisted Prioritization Software For Lesions1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 80 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 140 days; 3 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 0 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.

  • K183285cmTriageCuremetrix, Inc. · 20194cite it
  • K250754cmAngio® (V1.6)Curemetrix, Inc. · 20251cites it

What has FDA decided for it lately?

  • K260980cmAngio® V2.0Curemetrix, Inc. · 2026
  • K250754cmAngio® (V1.6)Curemetrix, Inc. · 2025
  • K232367cmAngio® V1.0Curemetrix, Inc. · 2023
  • K183285cmTriageCuremetrix, Inc. · 2019

All 4 as Curemetrix, Inc. →