FDA product code · Dental

Sterilizer, Boiling Water

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

ECGClass I21 CFR 872.6710510(k) required7 decisions since 19770 recalls

7 FDA decisions since 1977. No recall names this code.

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, dental panel

Twenty years of ECG 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.

FDA decisions per year · ECG

FDA has decided no ECG device since 2007.

Median 510(k) review, days · ECG

Too few ECG 510(k)s in any year since 2007 to give a median.

Recalls per year · ECG

No recall names ECG since 2007.

Adverse event reports per year · ECG

1in 2013

2007high 1 (2013) · low 0 (2007)2025

MAUDE reports naming product code ECG, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	1
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in ECG? 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

Sterilizer, Boiling Water

What has FDA decided in ECG lately?