510(k) · Cleared
ClearedIntervent Allergen Exclusion Technology, Intervent Bedding System, Intervent Mattress Interliner, Interview Pillow
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W. L. Gore & Associates, Inc. · FMW Cover, Mattress (Medical Purposes)
Cleared on Feb 25, 1994 after a 32-day review. FDA has not posted a summary or statement for it, so its predicates are not known.
- Decided
- Feb 25, 1994
- Review
- 32 days
- Class
- Class I
- Product code
- FMW
- Recalls
- None
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
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.
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?
FDA has not posted a summary or statement for it, so its predicates are not known.
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 | — |
https://510kreport.com/device/K940327 · printed Nov 4, 2026
Cite this page
510(k) Report. “K940327: Intervent Allergen Exclusion Technology, Intervent Bedding System, Intervent Mattress Interliner, Interview Pillow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K940327
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026