510(k) · Cleared
ClearedWet Chamber
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kinetic Concepts, Inc. · NAD Dressing, Wound, Occlusive
Cleared on May 6, 2002 as substantially equivalent to K991214 (Hollister, Inc., 1999) and 1 other predicate after a 56-day review. Its family tree reaches back 3 generations to 1981. 3 later devices descend from it.
- Decided
- May 6, 2002
- Review
- 56 days
- Class
- Class I
- Product code
- NAD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K811291 (1981). 6 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK811291 Tegaderm Transparent Dressing3M Company · 1981
- 2 generations backK961319 EpiviewConvatec, A Division of E.R. Squibb & Sons · 1996
- 1 generation backK991214 Simplicare Transparent Wound DressingHollister, Inc. · 1999
- This deviceK020781 Wet ChamberKinetic Concepts, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK060046 DermastreamEnzysurge, Ltd. · 2006
- Descendant · cites it directly · 0 of its ownK091133 Aplion Topical Care SystemAplion Medical,Llc · 2009
- Descendant · cites it directly · 0 of its ownK043063 Oxyband Wound DressingOxyband Technologies, Inc. · 2005
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 |
|---|---|---|---|---|---|
| −3 | K811291 | Tegaderm Transparent Dressing | 3M Company | 1981 | — |
| −2 | K961319 | Epiview | Convatec, A Division of E.R. Squibb & Sons | 1996 | — |
| −1 | K991214 | Simplicare Transparent Wound Dressing | Hollister, Inc. | 1999 | — |
| 0 (this device) | K020781 | Wet Chamber | Kinetic Concepts, Inc. | 2002 | — |
| +1 | K060046 | Dermastream | Enzysurge, Ltd. | 2006 | — |
| +1 | K091133 | Aplion Topical Care System | Aplion Medical,Llc | 2009 | — |
| +1 | K043063 | Oxyband Wound Dressing | Oxyband Technologies, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 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? (4)
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 |
|---|---|---|---|
| * | K991214 | Simplicare Transparent Wound DressingSummary page 1…edicate Devices: KCI Wound Cell Transparent Wound Dressing [510(k) Exempt] KCI Wet Cell Transparent Wound Dressing (510(k) Exempt] SimpliCare Transparent Wound Dressing (K991214) Innovative Technologies’ Transparent Film Dressing (K973312) FDA Regulatory Status: A final order published in the October 5,… | 1999 |
| * | K973312 | Transparent Film Dressing, Intelligent Film DressingSummary page 1…10(k) Exempt] KCI Wet Cell Transparent Wound Dressing (510(k) Exempt] SimpliCare Transparent Wound Dressing (K991214) Innovative Technologies’ Transparent Film Dressing (K973312) FDA Regulatory Status: A final order published in the October 5, 1999 Federal Register exempted occlusive . wound dressing fro… | 1997 |
| * | — | KCI Wound Cell Transparent Wound Dressing Named without a submission number | |
| * | — | KCI Wet Cell Transparent Wound Dressing Named without a submission number |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 21 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K060046 (Enzysurge, Ltd., 2006) has gone furthest, with 1 descendant of its own.
How does its category compare?
All NAD devicesNAD Dressing, Wound, Occlusive: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 KCI Wound Cell Transparent Dressing is intended to provide a moist wound healing environment to facilitate the normal wound healing process. The Dressing may also be used as a secondary fixation device for other topical wound treatments such as antimicrobial and enzymatic debriding solutions and suspensions, alginates, gels and foams.
The KCI Wound Cell Transparent Dressing is indicated for:
Non-exudating to minimally exuding wounds
Pressure sores
Lacerations/abrasions
Partial and full thickness wounds
Surgical incisions
Second degree burns
Donor sites
IV sites
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/K020781 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020781: Wet Chamber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020781
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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