510(k) · Cleared
ClearedDermassist Petrolatum Gauze,Usp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wilshire Medical Products · FRO Dressing, Wound, Drug
Cleared on Mar 3, 1994 as substantially equivalent to K921289 (Inman Medical Corp., 1992) after a 64-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Mar 3, 1994
- Review
- 64 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K921289 (1992). No later device cites it as a predicate yet.
- Root · 1 generation backK921289 Inman Medical Petrolatum DressingInman Medical Corp. · 1992
- This deviceK936230 Dermassist Petrolatum Gauze,UspWilshire Medical Products · 1994
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K921289 | Inman Medical Petrolatum Dressing | Inman Medical Corp. | 1992 | — |
| 0 (this device) | K936230 | Dermassist Petrolatum Gauze,Usp | Wilshire Medical Products | 1994 | — |
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K921289 | Inman Medical Petrolatum DressingSummary page 4…atum dressings have been in the market place. This product ts similar in design, composition and function to the Inman Medical Corporation Petrolatum Dressing, 510(k) # K921289 approved November 1992. Labeling claims are identical. A copy of the IMC 510(k) approval letter & product labeling may found on p… | 1992 |
| Kept off the family tree | K821231 | FDA’s K821231 is Vivonex Tungsten Tip Tube Placement Our OCR of the scanned summary read K821231, FDA’s number for Vivonex Tungsten Tip Tube Placement (Norwich Eaton Pharmaceuticals, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Inman Medical Corporation Petrolatum Dressing”. Kept off the family tree. Summary page 5…adhering dressings have in the market piace. This product is similar in design, composition and function to the Inman Medical Corporation Petroiatum Dressing, 510¢(k) # K821231approved January 1993, Labeling ciaims are identical, A DIVISION OF wiLsHIRE TECHNOLOGIES, INC. | 1982 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K921289.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Indications are for first and second degree burns, partial thickness wounds, donor sites, chest tubes, stomas and fistulas, circumcisions and abrasions.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K936230 · printed Nov 6, 2026
Cite this page
510(k) Report. “K936230: Dermassist Petrolatum Gauze,Usp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K936230
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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