510(k) · Cleared
ClearedAbram's Multi-Density Polyurethane Foam Wound Dressing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dr. Len'S Medical Products, LLC · FRO Dressing, Wound, Drug
Cleared on Sep 7, 2004 as substantially equivalent to K002129 (Ferris Mfg. Corp., 2000) and 1 other predicate after a 343-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Sep 7, 2004
- Review
- 343 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K946245 (1995). 7 ancestors in all, the oldest K871166 (1987). No later device cites it as a predicate yet.
- Root · 3 generations backK946245 Tielle* Hydropolymer DressingJohnson & Johnson International · 1995
- 2 generations backK983173 Biatain Foam Adhesive DressingColoplast Corp. · 1998
- 1 generation backK022416 Contreet Foam Adhesive/Non-AdhesiveColoplast Corp. · 2003
- This deviceK033164 Abram's Multi-Density Polyurethane Foam Wound Dressing SystemDr. Len'S Medical Products, LLC · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K946245 | Tielle* Hydropolymer Dressing | Johnson & Johnson International | 1995 | — |
| −2 | K983173 | Biatain Foam Adhesive Dressing | Coloplast Corp. | 1998 | — |
| −1 | K022416 | Contreet Foam Adhesive/Non-Adhesive | Coloplast Corp. | 2003 | — |
| 0 (this device) | K033164 | Abram's Multi-Density Polyurethane Foam Wound Dressing System | Dr. Len'S Medical Products, LLC | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 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 |
|---|---|---|---|
| * | K002129 | Ferris Polymem Sterile Wound Dressing with CollagenSummary page 1…l Equivalency is claimed against the following device: · Ferris Polymem Sterile Wound Dressing with Collagen from Ferris Manufacturing Corporation, 510k #K002129 * Contreet Foam Adhesive/Non-Adhesive from Coloplast Corporation, 510k #K 022416 11-Description of the Device: T… | 2000 |
| * | K022416 | Contreet Foam Adhesive/Non-AdhesiveSummary page 1…Wound Dressing with Collagen from Ferris Manufacturing Corporation, 510k #K002129 * Contreet Foam Adhesive/Non-Adhesive from Coloplast Corporation, 510k #K 022416 11-Description of the Device: The patented Abrams Multi-Density Polyurethane Foam Wound Dressing System is a single-patient use… | 2003 |
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 9 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- None of the 7 ancestors has a recall.
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?
This device is indicated for use for the treatment of pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, surgical wounds, trauma wounds (abrasions, lacerations, second degree burns) and draining wounds.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033164 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033164: Abram's Multi-Density Polyurethane Foam Wound Dressing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033164
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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