510(k) · Cleared
ClearedAllergy Control Covers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allergy Control Products, Inc. · FMW Cover, Mattress (Medical Purposes)
Cleared on Nov 2, 1990 after a 98-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Nov 2, 1990
- Review
- 98 days
- Class
- Class I
- Product code
- FMW
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK903382 Allergy Control CoversAllergy Control Products, Inc. · 1990
- Descendant · cites it directly · 1 of its ownK061242 Dermatherapy, Model 22216Precision Fabrics Group, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK152884 DermaTherapy Bed LinensPrecision Fabrics Group, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK001003 Z-NETDemite Limited · 2001
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K903382 | Allergy Control Covers | Allergy Control Products, Inc. | 1990 | — |
| +1 | K061242 | Dermatherapy, Model 22216 | Precision Fabrics Group, Inc. | 2007 | — |
| +2 | K152884 | DermaTherapy Bed Linens | Precision Fabrics Group, Inc. | 2016 | — |
| +1 | K001003 | Z-NET | Demite Limited | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2007 | 1 | 0 |
| 2016 | 1 | 0 |
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? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
What does this lineage say?
- Of its descendants, K061242 (Precision Fabrics Group, Inc., 2007) has gone furthest, with 1 descendant of its own.
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/K903382 · printed Nov 4, 2026
Cite this page
510(k) Report. “K903382: Allergy Control Covers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K903382
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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