FDA product code · General hospital

Injection Data Capture Device

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

QOGClass II21 CFR 880.5860510(k) required7 decisions since 20220 recalls

7 FDA decisions since 2022. 510(k) reviews decided 2021–2025 took a median of 90 days (half between 46 and 229). No recall names this code. The most-cited predicate is K222689, named by 2 later devices.

An injection data capture device is an electrically-powered/electromechanical accessory that interfaces with reusable or disposable injection devices for the purposes of interpreting, recording and displaying and/or transmitting injection data to a connected application or software.

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, general hospital panel

Twenty years of QOG 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 · QOG

3in 2025

2007high 3 (2025) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QOG

30in 2025

2007high 30 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · QOG

No recall names QOG since 2007.

Adverse event reports per year · QOG

1in 2022

2007high 1 (2022) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	2	—	1
2023	0	—	0
2024	2	—	0
2025	3	30	0
2026	0	—	—

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

Planning a device in QOG? 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 880.5860.

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Injection Data Capture Device

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What has FDA decided in QOG lately?

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