510(k) Report

FDA product code · Cardiovascular

Valvular Regurgitation Machine Learning-Based Notification Software

SIJClass II21 CFR 870.2380510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

Valvular regurgitation machine learning-based notification software employs machine learning techniques to suggest the likelihood of valvular regurgitation for further referral or diagnostic follow-up.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, cardiovascular panel

Twenty years of SIJ at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FIG. 1 — SIJ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in SIJ? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 870.2380.

SAT Pulmonary Hypertension Machine Learning-Based…SBQ Atrial Fibrillation Risk Prediction Machine…SFR Hypertension Machine Learning-Based…SIK Cardiac Hypertrophy Machine Learning-Based…QYE Reduced Ejection Fraction Machine…SII Aortic Stenosis Machine Learning-Based…QXO Cardiovascular Machine Learning-Based…SHP Cardiac Amyloidosis Machine Learning-Based…QXX Coronary Artery Disease Machine Learning-Based…