510(k) · Cleared
ClearedDynarex Xeroform Petrolatum Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dynarex Corporation · FRO Dressing, Wound, Drug
Cleared on Oct 3, 2016 as substantially equivalent to K973507 (Kendall Healthcare Products Co. Div.Of Tyco Health, 1997) after a 361-day review. Its family tree reaches back 1 generation to 1997. 3 later devices descend from it.
- Decided
- Oct 3, 2016
- Review
- 361 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K973507 (1997). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK973507 Kendall Xeroform Petrolatum Dressing…Kendall Healthcare Products Co. Div.Of Tyco Health · 1997
- This deviceK152970 Dynarex Xeroform Petrolatum DressingDynarex Corporation · 2016
- Descendant · cites it directly · 2 of its ownK181478 Roosin Xeroform Petrolatum DressingRoosin Medical Co., Ltd. · 2019
- Descendant · 2 generations on · 1 of its ownK193439 MEBO Wound DressingMebo Life Science, Inc. · 2020
- Descendant · 3 generations on · 0 of its ownK222657 MEBO Wound DressingMebo Life Science, Inc. · 2022
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 |
|---|---|---|---|---|---|
| −1 | K973507 | Kendall Xeroform Petrolatum Dressing (6311,6312,6313,6314,6315,6316,6317) | Kendall Healthcare Products Co. Div.Of Tyco Health | 1997 | — |
| 0 (this device) | K152970 | Dynarex Xeroform Petrolatum Dressing | Dynarex Corporation | 2016 | — |
| +1 | K181478 | Roosin Xeroform Petrolatum Dressing | Roosin Medical Co., Ltd. | 2019 | — |
| +2 | K193439 | MEBO Wound Dressing | Mebo Life Science, Inc. | 2020 | — |
| +3 | K222657 | MEBO Wound Dressing | Mebo Life Science, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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? (1)
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 |
|---|---|---|---|
| * | K973507 | Kendall Xeroform Petrolatum Dressing (6311,6312,6313,6314,6315,6316,6317)Summary page 5…Kendall Xeroform Kendall Healthcare Products FRO K973507 Petrolatum Wound Company… | 1997 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181478 | Roosin Xeroform Petrolatum Dressing | 2019 | 2 |
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.
- Of its descendants, K181478 (Roosin Medical Co., Ltd., 2019) has gone furthest, with 2 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?
Dynarex Xeroform Petrolatum Dressing is intended for use as a primary contact layer in dressing wounds such as lacerations, skin graft recipient sites, newly sutured wounds, abrasions, and minor and partial thickness burns. It may also be used as an initial layer in dressing surgical wounds with light exudate.
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/K152970 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152970: Dynarex Xeroform Petrolatum Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152970
Report an extraction error
Are you the manufacturer?
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