510(k) · Cleared
ClearedAplion Topical Care System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aplion Medical,Llc · NAD Dressing, Wound, Occlusive
Cleared on May 20, 2009 as substantially equivalent to K020781 (Kinetic Concepts, Inc., 2002) and 1 other predicate after a 30-day review. Its family tree reaches back 5 generations to 1981.
- Decided
- May 20, 2009
- Review
- 30 days
- Class
- Class I
- Product code
- NAD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K811291 (1981). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK811291 Tegaderm Transparent Dressing3M Company · 1981
- 4 generations backK961319 EpiviewConvatec, A Division of E.R. Squibb & Sons · 1996
- 3 generations backK991214 Simplicare Transparent Wound DressingHollister, Inc. · 1999
- 2 generations backK020781 Wet ChamberKinetic Concepts, Inc. · 2002
- 1 generation backK060046 DermastreamEnzysurge, Ltd. · 2006
- This deviceK091133 Aplion Topical Care SystemAplion Medical,Llc · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K811291 | Tegaderm Transparent Dressing | 3M Company | 1981 | — |
| −4 | K961319 | Epiview | Convatec, A Division of E.R. Squibb & Sons | 1996 | — |
| −3 | K991214 | Simplicare Transparent Wound Dressing | Hollister, Inc. | 1999 | — |
| −2 | K020781 | Wet Chamber | Kinetic Concepts, Inc. | 2002 | — |
| −1 | K060046 | Dermastream | Enzysurge, Ltd. | 2006 | — |
| 0 (this device) | K091133 | Aplion Topical Care System | Aplion Medical,Llc | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 3 | 0 |
| 2000 | 1 | 0 |
| 2002 | 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 NAD? 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 NAD device
- #1 K254246 LT Antibacterial Foam with Silver Dressingscore 13.5 · 6 generations · no Class I recall
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 |
|---|---|---|---|
| * | K020781 | Wet ChamberSummary page 1…Aplion Topical Care System Common Name: Occlusive Wound Dressing B. Name of Predicate Device(s) * Occlusive Wound Dressing (Product Code - NAD): K020781 Kinetic Concepts, Inc., Wound Cell Transparent Dressing * Occlusive Wound Dressing (Product Code - NAD): K060046 E… | 2002 |
| * | K060046 | DermastreamSummary page 1…Occlusive Wound Dressing (Product Code - NAD): K020781 Kinetic Concepts, Inc., Wound Cell Transparent Dressing * Occlusive Wound Dressing (Product Code - NAD): K060046 Enzysurge, Ltd., Dermastream C. Device Description An occlusive wound dressing is a nonresorbable, sterile or non-ster… | 2006 |
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 28 years and passes through 6 companies; a new generation was cleared every 3.3 years on median.
- None of the 14 ancestors has a recall.
- 2 other devices also cite its predicate K020781.
How does its category compare?
All NAD devicesNAD Dressing, Wound, Occlusive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · NAD
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · NAD
Too few NAD 510(k)s in any year since 2007 to give a median.
Recalls per year · NAD
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NAD
2,619in 2025
MAUDE reports naming product code NAD, 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 | 0 | — | 0 | 1 |
| 2008 | 2 | — | 0 | 8 |
| 2009 | 1 | — | 0 | 9 |
| 2010 | 0 | — | 1 | 30 |
| 2011 | 1 | — | 0 | 9 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 15 |
| 2014 | 0 | — | 1 | 63 |
| 2015 | 0 | — | 0 | 251 |
| 2016 | 0 | — | 0 | 106 |
| 2017 | 0 | — | 0 | 134 |
| 2018 | 0 | — | 6 | 1,029 |
| 2019 | 0 | — | 0 | 588 |
| 2020 | 0 | — | 0 | 5,035 |
| 2021 | 0 | — | 0 | 451 |
| 2022 | 0 | — | 1 | 403 |
| 2023 | 0 | — | 0 | 1,619 |
| 2024 | 0 | — | 0 | 1,804 |
| 2025 | 0 | — | 1 | 2,619 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Aplion Topical Care System is an occlusive wound dressing which is intended to provide a moist wound healing environment to facilitate the normal wound healing process. It also permits the introduction of topical wound treatment solutions and suspensions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091133 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091133: Aplion Topical Care System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091133
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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