510(k) · Cleared
ClearedEnvela (Hydrohesive Occlusive Dressing)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teikoku Pharma USA, Inc. · NAD Dressing, Wound, Occlusive
Cleared on Jun 17, 2008 after a 280-day review. The FDA summary names its predicate without a number.
- Decided
- Jun 17, 2008
- Review
- 280 days
- Class
- Class I
- Product code
- NAD
- 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 NAD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NAD device
- #1 K254246 LT Antibacterial Foam with Silver Dressingscore 13.5 · 6 generations · no Class I recall
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | — | DuoDerm® Extra Thin (Extra Thin® CGF Dressing) Named without a submission number | |
| * | — | Compeed Psoriasis Dressing Named without a submission number | |
| * | — | Hydrocolloid Dressing for Psoriasis 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 NAD devicesNAD Dressing, Wound, Occlusive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · NAD
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · NAD
Too few NAD 510(k)s in any year since 2007 to give a median.
Recalls per year · NAD
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NAD
2,619in 2025
MAUDE reports naming product code NAD, 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 | 1 |
| 2008 | 2 | — | 0 | 8 |
| 2009 | 1 | — | 0 | 9 |
| 2010 | 0 | — | 1 | 30 |
| 2011 | 1 | — | 0 | 9 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 15 |
| 2014 | 0 | — | 1 | 63 |
| 2015 | 0 | — | 0 | 251 |
| 2016 | 0 | — | 0 | 106 |
| 2017 | 0 | — | 0 | 134 |
| 2018 | 0 | — | 6 | 1,029 |
| 2019 | 0 | — | 0 | 588 |
| 2020 | 0 | — | 0 | 5,035 |
| 2021 | 0 | — | 0 | 451 |
| 2022 | 0 | — | 1 | 403 |
| 2023 | 0 | — | 0 | 1,619 |
| 2024 | 0 | — | 0 | 1,804 |
| 2025 | 0 | — | 1 | 2,619 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
-For use in the management of psoriasis and the protection of psoriatic plaques
-As a protective dressing
- For management of superficial, dry to lightly exudating dermal wounds.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072560 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072560: Envela (Hydrohesive Occlusive Dressing).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072560
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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