FDA product code · Immunology

System, Test, Her-2/Neu, Monitoring

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

NCWClass II21 CFR 866.6010510(k) required3 decisions since 20001 recall

3 FDA decisions since 2000. 1 recall names this code; it is not Class I. The most-cited predicate is K992228, 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)

FIG. A — Illustration, immunology panel

Twenty years of NCW 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 · NCW

FDA has decided no NCW device since 2007.

Median 510(k) review, days · NCW

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

Recalls per year · NCW

1in 2020

2007high 1 (2020) · low 0 (2007)2026

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

Adverse event reports per year · NCW

No MAUDE report names NCW since 2007.

View these four charts as a table

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

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

Planning a device in NCW? 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 866.6010.

OXP Dna-Probe Kit, Human Chromosome X And Y, Bmt…MUT Kit, Test For Nuclear Matrix (Numa) Protein…MSW System, Test, Thyroglobulin MOI System, Test, Immunological, Antigen, Tumor DHX System, Test, Carcinoembryonic Antigen NVA Cancer Monitoring Test System, Soluble…NIG System, Test, Carbohydrate Antigen (Ca19-9)…OIU Test, Epithelial Ovarian Tumor Associated…LTJ Prostate-Specific Antigen (Psa) For Management…QXS Chromogranin A LOQ Device, General Purpose, Hematology OVK Cytokeratin Fragments 21-1 Eia Kit

System, Test, Her-2/Neu, Monitoring

Which predicates do NCW devices cite most?

Which NCW devices have the deepest lineage?

What has FDA decided in NCW lately?

What has been recalled in NCW lately?

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