510(k) · Cleared
ClearedPuraDERM Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3-D Matrix, Inc. · FRO Dressing, Wound, Drug
Cleared on May 11, 2020 as substantially equivalent to K143058 (3-D Matrix, Inc., 2015) and 1 other predicate after a 188-day review. Its family tree reaches back 3 generations to 1989.
- Decided
- May 11, 2020
- Review
- 188 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K894541 (1989). 5 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K894541 | Carrington Dermal Wound Gel | Carrington Laboratories, Inc. | 1989 | — |
| −2 | K991202 | Modification to Woun'dres | Coloplast Corp. | 1999 | — |
| −1 | K143058 | PuraDerm Gel | 3-D Matrix, Inc. | 2015 | — |
| 0 (this device) | K193085 | PuraDERM Gel | 3-D Matrix, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1997 | 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? (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 |
|---|---|---|---|
| * | K143058 | PuraDerm GelSummary page 4…ressing Classification Regulation/Class: Unclassified Product Code: FRO Panel: General and Plastic Surgery 3. PREDICATE DEVICE Predicate Devices: PuraDerm Gel (K143058) and Woun’Dres (K991202) 4. DEVICE DESCRIPTION Description PuraDerm Gel consists of a synthetic, peptide-based hydrogel… | 2015 |
| * | K991202 | Modification to Woun'dresSummary page 4…egulation/Class: Unclassified Product Code: FRO Panel: General and Plastic Surgery 3. PREDICATE DEVICE Predicate Devices: PuraDerm Gel (K143058) and Woun’Dres (K991202) 4. DEVICE DESCRIPTION Description PuraDerm Gel consists of a synthetic, peptide-based hydrogel material provided in a… | 1999 |
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.
What does this lineage say?
- The line of descent spans 31 years and passes through 3 companies; a new generation was cleared every 9.5 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K143058.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
PuraDerm Gel is indicated for the hydration and management of partial and full thickness wounds, such as pressure sores, leg ulcers, diabetic ulcers, surgical wounds, and abrasions and burns associated with dermabrasion and laser resurfacing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193085 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193085: PuraDERM Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193085
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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