510(k) · Cleared

Recalled · Class I · 2022

Reactive Skin Decontamination Lotion

K023969510(k) TraditionalCleared Mar 25, 2003116-day reviewClass I21 CFR 878.4014Recalls 1 (1 Class I)

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Dept. of the Army · MAC Decontamination Kit

Cleared on Mar 25, 2003 as substantially equivalent to K894455 (Dept. of the Army, 1989) after a 116-day review. Its family tree reaches back 1 generation to 1989. 1 of the 2 devices in its family, counting itself, has a Class I recall. It has been recalled once, including a Class I recall.

Decided: Mar 25, 2003
Review: 116 days
Class: Class I
Product code: MAC
Recalls: 1 (1 Class I)
Predicates: 1

Its longest line of descent runs back 1 generation to K894455 (1989). No later device cites it as a predicate yet. 1 of the 2 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK894455 Decontaminating Kit, Skin: M291Dept. of the Army · 1989
This deviceK023969 Reactive Skin Decontamination LotionDept. of the Army · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K894455	Decontaminating Kit, Skin: M291	Dept. of the Army	1989	—
0 (this device)	K023969	Reactive Skin Decontamination Lotion	Dept. of the Army	2003	—

FIG. 1 — Lineage of K023969, 1989–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K894455	Decontaminating Kit, Skin: M291 Summary page 1 …e: Reactive Skin Decontamination Lotion (RSDL) Device Common Name: Kit, Decontamination Classification Name: MAC Predicate Device: K894455, U.S. Department of the Army, Decontaminating Kit, Skin: M291 Device Description: T…	Dept. of the Army	1989	—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 24, 2022	Class I	Z-0773-2023	Packaging change control	Complaints of leaking packets were received.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.

How does its category compare?

All MAC devices

MAC Decontamination Kit: FDA decisions, review times, recalls and adverse event reports over 20 years.

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	—

What is it indicated for?

The Reactive Skin Decontamination Lotion is intended to remove or neutralize chemical warfare agents and T-2 toxin from the skin.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K023969 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023969: Reactive Skin Decontamination Lotion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023969

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026