510(k) · Cleared
ClearedKendall Xeroform Petrolatum Dressing (6311,6312,6313,6314,6315,6316,6317)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kendall Healthcare Products Co. Div.Of Tyco Health · FRO Dressing, Wound, Drug
Cleared on Dec 15, 1997 after a 90-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Dec 15, 1997
- Review
- 90 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK973507 Kendall Xeroform Petrolatum Dressing…Kendall Healthcare Products Co. Div.Of Tyco Health · 1997
- Descendant · cites it directly · 3 of its ownK152970 Dynarex Xeroform Petrolatum DressingDynarex Corporation · 2016
- Descendant · 2 generations on · 2 of its ownK181478 Roosin Xeroform Petrolatum DressingRoosin Medical Co., Ltd. · 2019
- Descendant · 3 generations on · 1 of its ownK193439 MEBO Wound DressingMebo Life Science, Inc. · 2020
- Descendant · 4 generations on · 0 of its ownK222657 MEBO Wound DressingMebo Life Science, Inc. · 2022
Most influential descendants
Showing 4 of 4 · See all- K152970Dynarex Xeroform Petrolatum DressingDynarex Corporation · 2016 · cites it directly3descendants
- K181478Roosin Xeroform Petrolatum DressingRoosin Medical Co., Ltd. · 2019 · 2 generations on2descendants
- K193439MEBO Wound DressingMebo Life Science, Inc. · 2020 · 3 generations on1descendant
- K222657MEBO Wound DressingMebo Life Science, Inc. · 2022 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973507 | Kendall Xeroform Petrolatum Dressing (6311,6312,6313,6314,6315,6316,6317) | Kendall Healthcare Products Co. Div.Of Tyco Health | 1997 | — |
| +1 | K152970 | Dynarex Xeroform Petrolatum Dressing | Dynarex Corporation | 2016 | — |
| +2 | K181478 | Roosin Xeroform Petrolatum Dressing | Roosin Medical Co., Ltd. | 2019 | — |
| +3 | K193439 | MEBO Wound Dressing | Mebo Life Science, Inc. | 2020 | — |
| +4 | K222657 | MEBO Wound Dressing | Mebo Life Science, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | — | Sherwood Medical Xeroform Petrolatum Dressing Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152970 | Dynarex Xeroform Petrolatum Dressing | 2016 | 3 |
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?
- Of its descendants, K152970 (Dynarex Corporation, 2016) has gone furthest, with 3 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.
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?
It 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 or partial thickness burns. It may also be used as an initial layer in dressing surgical wounds with light exudate where mild medication and deodorization are desired.
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/K973507 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973507: Kendall Xeroform Petrolatum Dressing (6311,6312,6313,6314,6315,6316,6317).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973507
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