FDA product code · General hospital

Decontamination Kit

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

MACClass I21 CFR 878.40142 decisions since 19891 recall

2 FDA decisions since 1989. 1 recall names this code; it is Class I. The most-cited predicate is K894455, named by 1 later device.

This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. 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…

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 MAC 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 · MAC

FDA has decided no MAC device since 2007.

Median 510(k) review, days · MAC

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

Recalls per year · MAC

1in 2022

2007high 1 (2022) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · MAC

2in 2025

2007high 7 (2023) · low 0 (2007)2025

MAUDE reports naming product code MAC, 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	1
2010	—	0	0
2011	—	0	1
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	1
2021	—	0	0
2022	—	1 (1)	0
2023	—	0	7
2024	—	0	1
2025	—	0	2
2026	—	0	—

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

Planning a device in MAC? 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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Other codes under 21 CFR 878.4014.

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Decontamination Kit

Which predicates do MAC devices cite most?

Which MAC devices have the deepest lineage?

What has FDA decided in MAC lately?

What has been recalled in MAC lately?

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