510(k) · Cleared
ClearedDecontaminating Kit, Skin: M291
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dept. of the Army · MAC Decontamination Kit
Cleared on Aug 15, 1989 after a 21-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 2 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Aug 15, 1989
- Review
- 21 days
- Class
- Class I
- Product code
- MAC
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly. 1 of the 2 devices in this family, counting this one, has a Class I recall.
- This deviceK894455 Decontaminating Kit, Skin: M291Dept. of the Army · 1989
- Descendant · cites it directly · 0 of its ownK023969 Reactive Skin Decontamination LotionDept. of the Army · 2003 · Recalled (Class I)
Class I recalls in this family
- K023969 Reactive Skin Decontamination Lotioncites it directly · 2003
Most influential descendants
Showing 1 of 1 · See all- K023969Reactive Skin Decontamination LotionDept. of the Army · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K894455 | Decontaminating Kit, Skin: M291 | Dept. of the Army | 1989 | — |
| +1 | K023969 | Reactive Skin Decontamination Lotion | Dept. of the Army | 2003 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 1 |
Sources: FDA 510(k) database (decision fields), 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
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023969 | Reactive Skin Decontamination Lotion Class I | 2003 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K023969Reactive Skin Decontamination LotionDept. of the Army · 2003 · Cites it directly · ◆ in the 2003 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K023969 (Dept. of the Army, 2003) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MAC devicesMAC 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
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAC
2in 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 | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 1 (1) | 0 |
| 2023 | 0 | — | 0 | 7 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K894455 · printed Nov 6, 2026
Cite this page
510(k) Report. “K894455: Decontaminating Kit, Skin: M291.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K894455
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026