FDA product code · Anesthesiology

Tracheotomy Care Kit

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

NXAClass II21 CFR 868.58001 decision since 19856 recalls

1 FDA decision since 1985. 6 recalls name this code, 3 of them Class I.

This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

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, anesthesiology panel

Twenty years of NXA 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 · NXA

FDA has decided no NXA device since 2007.

Median 510(k) review, days · NXA

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

Recalls per year · NXA

1in 2024

2007high 2 (2023) · low 0 (2007)2026

Class I (3 since 2007) Class II/III not classified

Adverse event reports per year · NXA

1in 2023

2007high 4 (2022) · low 0 (2007)2025

MAUDE reports naming product code NXA, 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	—	0	0
2012	—	0	0
2013	—	0	0
2014	—	1 (1)	0
2015	—	0	0
2016	—	0	0
2017	—	0	0
2018	—	0	1
2019	—	0	1
2020	—	0	1
2021	—	0	0
2022	—	1	4
2023	—	2 (2)	1
2024	—	1	0
2025	—	0	0
2026	—	1	—

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

Planning a device in NXA? 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 868.5800.

OGW Tracheostomy Kit BTO Tube, Tracheostomy (W/Wo Connector)JOH Tube Tracheostomy And Tube Cuff OGP Cricothyrotomy Kit OGV Tracheostomy Cleaning Tray

Tracheotomy Care Kit

What has FDA decided in NXA lately?

What has been recalled in NXA lately?

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