510(k) Report

FDA applicant

Anumana, Inc.

Cambridge, MA6 decisions2023–20260 recalls

FDA records 6 decisions for Anumana, Inc. (Cambridge, MA) from 2023 to 2026: 6 510(k) clearances. Most are in product codes QYE (Reduced Ejection Fraction Machine…) and SHP (Cardiac Amyloidosis Machine Learning-Based…). Since 2016 its 510(k)s took a median of 136 days from receipt to decision, against 133 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 3 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2025

2023: 22025: 12026 (partial year): 3
2023high 3 (2026) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Anumana, Inc. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Anumana, 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?

  • QYEReduced Ejection Fraction Machine Learning-Based Notification Software2decisions
  • SHPCardiac Amyloidosis Machine Learning-Based Notification Software1decision
  • DQKComputer, Diagnostic, Programmable1decision
  • SATPulmonary Hypertension Machine Learning-Based Notification Software1decision
  • QIHAutomated Radiological Image Processing Software1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 136 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 133 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 3 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.

  • K232699Low Ejection Fraction AI-ECG AlgorithmAnumana, Inc. · 20234cite it
  • K250652ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)Anumana, Inc. · 20253cite it
  • K252360ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)Anumana, Inc. · 20261cites it

What has FDA decided for it lately?

  • K260300WatchMate SoftwareAnumana, Inc. · 2026
  • K253801ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)Anumana, Inc. · 2026
  • K252360ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)Anumana, Inc. · 2026
  • K250652ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)Anumana, Inc. · 2025
  • K233160NeuTrace EP Mapping System v.2.1Anumana, Inc. · 2023
  • K232699Low Ejection Fraction AI-ECG AlgorithmAnumana, Inc. · 2023

All 6 as Anumana, Inc. →