510(k) · Cleared
ClearedEvent Allergen Barriers, Event Mattress Encasing, Event Duvet Encasing, Event Pillow Encasing, Event Bedding System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allergy Direct · FMW Cover, Mattress (Medical Purposes)
Cleared on Nov 8, 1999 after an 88-day review. The FDA summary names its predicate without a number.
- Decided
- Nov 8, 1999
- Review
- 88 days
- Class
- Class I
- Product code
- FMW
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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.
Planning a device in FMW? 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? (2)
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 | Decided |
|---|---|---|---|
| * | — | ACb™ Elite Named without a submission number | |
| * | — | ACb™ Sheer Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All FMW devicesFMW Cover, Mattress (Medical Purposes): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FMW
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · FMW
Too few FMW 510(k)s in any year since 2007 to give a median.
Recalls per year · FMW
2in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FMW
2in 2025
MAUDE reports naming product code FMW, 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 | 1 | — | 2 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 19 |
| 2012 | 0 | — | 0 | 13 |
| 2013 | 0 | — | 0 | 32 |
| 2014 | 0 | — | 0 | 22 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
eVENT™ Allergen Barriers have been designed exclusively for allergy sufferers wishing to reduce their exposure to house dust mite allergens in mattresses, pillows and duvet/comforters.
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/K992702 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992702: Event Allergen Barriers, Event Mattress Encasing, Event Duvet Encasing, Event Pillow Encasing, Event Bedding System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992702
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026