FDA product code

Medical device product code

Name: FDA decisions, review times, recalls and adverse event reports for product code ORE
Creator: 510(k) Report

ORE1 decision since 20240 recalls

1 FDA decision since 2024. No recall names this code. The most-cited predicate is K240226, named by 1 later device.

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)

Twenty years of ORE 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 — ORE by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in ORE? 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

Medical device product code

Which predicates do ORE devices cite most?

Which ORE devices have the deepest lineage?

What has FDA decided in ORE lately?