FDA product code · General hospital

Container, Specimen, Non-Sterile

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

NNIClass I21 CFR 864.3250510(k) exempt0 decisions3 recalls

FDA lists NNI as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 864.9 applies, such as a new intended use or a different fundamental technology. 0 FDA decisions. 3 recalls name this code, 0 of them Class I.

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 NNI 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 · NNI

FDA has decided no NNI device since 2007.

Median 510(k) review, days · NNI

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

Recalls per year · NNI

1in 2021

2007high 1 (2011) · low 0 (2007)2026

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

Adverse event reports per year · NNI

1in 2024

2007high 5 (2020) · low 0 (2007)2025

MAUDE reports naming product code NNI, 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	—	0	0
2008	—	0	0
2009	—	0	0
2010	—	0	0
2011	—	1	4
2012	—	0	3
2013	—	0	0
2014	—	0	2
2015	—	0	2
2016	—	0	0
2017	—	0	2
2018	—	0	0
2019	—	0	1
2020	—	0	5
2021	—	1	4
2022	—	0	3
2023	—	0	0
2024	—	0	1
2025	—	0	0
2026	—	1	—

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

Planning a device in NNI? 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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Container, Specimen, Non-Sterile

What has been recalled in NNI lately?

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