510(k) · Cleared
ClearedPermeaDerm B, PermeaDerm CW, and PermeaDerm Glove
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Permeaderm, Inc. · FRO Dressing, Wound, Drug
Cleared on Aug 8, 2016 as substantially equivalent to K091863 (Aubrey, Inc., 2010) and 2 other predicates after a 231-day review. Its family tree reaches back 2 generations to 2009. 1 later device descends from it.
- Decided
- Aug 8, 2016
- Review
- 231 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K082869 (2009). 4 ancestors in all, the oldest K790496 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK082869 Awbat-S, Awbat-D, Awbat-MAubrey, Inc. · 2009
- 1 generation backK091863 Awbat-S Plus, Awbat-D Plus, Awbat-M PlusAubrey, Inc. · 2010
- This deviceK153678 PermeaDerm B, PermeaDerm CW, and PermeaDerm GlovePermeaderm, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK212579 FortiShield (Biosynthetic Wound Matrix)Organogenesis, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K212579FortiShield (Biosynthetic Wound Matrix)Organogenesis, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K082869 | Awbat-S, Awbat-D, Awbat-M | Aubrey, Inc. | 2009 | — |
| −1 | K091863 | Awbat-S Plus, Awbat-D Plus, Awbat-M Plus | Aubrey, Inc. | 2010 | — |
| 0 (this device) | K153678 | PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove | Permeaderm, Inc. | 2016 | — |
| +1 | K212579 | FortiShield (Biosynthetic Wound Matrix) | Organogenesis, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
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 FRO? 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 FRO device
- #1 K261023 Microdacyn Wound Irrigation Solutionscore 15.5 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K091863 | Awbat-S Plus, Awbat-D Plus, Awbat-M PlusSummary page 4…Unclassified Product Code: FRO 6.0 Predicate Devices Name AWBAT Plus Biobrane Oasis 510(k) number K091863 K790496 K061711 Trade Names AWBAT Plus Biobrane Oasis… | 2010 |
| * | K790496 | Biobrane Brand Temporary Wound DressingSummary page 4…uct Code: FRO 6.0 Predicate Devices Name AWBAT Plus Biobrane Oasis 510(k) number K091863 K790496 K061711 Trade Names AWBAT Plus Biobrane Oasis Wound… | 1979 |
| * | K061711 | Oasis Wound MatrixSummary page 4…icate Devices Name AWBAT Plus Biobrane Oasis 510(k) number K091863 K790496 K061711 Trade Names AWBAT Plus Biobrane Oasis Wound… | 2006 |
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 |
|---|---|---|---|
| K212579 | FortiShield (Biosynthetic Wound Matrix) | 2023 | 0 |
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?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 6.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K212579 (Organogenesis, Inc., 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · FRO
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRO
176in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRO
2in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · FRO
192in 2025
MAUDE reports naming product code FRO, 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 | 29 | 187 | 4 | 55 |
| 2008 | 26 | 130 | 1 | 30 |
| 2009 | 31 | 136 | 1 | 45 |
| 2010 | 31 | 146 | 0 | 122 |
| 2011 | 27 | 177 | 4 | 42 |
| 2012 | 24 | 96 | 0 | 65 |
| 2013 | 19 | 194 | 1 | 139 |
| 2014 | 22 | 214 | 1 | 269 |
| 2015 | 28 | 249 | 2 | 297 |
| 2016 | 28 | 222 | 3 | 147 |
| 2017 | 23 | 147 | 1 | 149 |
| 2018 | 20 | 206 | 0 | 128 |
| 2019 | 16 | 270 | 1 | 136 |
| 2020 | 12 | 226 | 0 | 139 |
| 2021 | 8 | 275 | 6 | 183 |
| 2022 | 9 | 332 | 2 | 176 |
| 2023 | 18 | 283 | 2 (2) | 198 |
| 2024 | 24 | 263 | 2 | 232 |
| 2025 | 11 | 176 | 0 | 192 |
| 2026 | 17 | 254 | 2 | — |
What is it indicated for?
PermeaDerm B, CW and Glove are intended for use as wound coverings and to provide a moist wound healing environment on cleanly debrided wounds after hemostasis has been established.
PermeaDerm B is indicated for partial thickness burn wounds, donor sites and coverage of meshed autograft.
PermeaDerm CW is indicated for partial thickness wounds, pressure sores, venous ulcers, diabetic ulcers, chronic vascular ulcers, surgical wounds (donor sites/grafts, post-Moh’s, post-laser surgery, podiatric, wound dehiscence, trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) and draining wounds.
PermeaDerm Glove is indicated for debrided partial thickness hand burns.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153678 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153678: PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153678
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026