FDA product code · Immunology

Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease

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

NVIClass II21 CFR 862.3100510(k) required1 decision since 20051 recall

1 FDA decision since 2005. 1 recall names this code; it is not Class I. The most-cited predicate is K043341, named by 2 later devices.

The device is intended to suggest a systemic autoimmune disease association as an aid for differential diagnosis to be evaluated in conjunction with clinical findings and other laboratory tests.

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, immunology panel

Twenty years of NVI 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 · NVI

FDA has decided no NVI device since 2007.

Median 510(k) review, days · NVI

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

Recalls per year · NVI

1in 2007

2007high 1 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NVI

1in 2019

2007high 1 (2019) · low 0 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	1	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	1
2020	—	0	0
2021	—	0	0
2022	—	0	0
2023	—	0	0
2024	—	0	0
2025	—	0	0
2026	—	0	—

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

Planning a device in NVI? 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

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Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease

Which predicates do NVI devices cite most?

Which NVI devices have the deepest lineage?

What has FDA decided in NVI lately?

What has been recalled in NVI lately?

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