510(k) · Cleared
ClearedSimplicare Transparent Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hollister, Inc. · MGP Dressing, Wound And Burn, Occlusive
Cleared on Oct 14, 1999 as substantially equivalent to K923235 (Johnson & Johnson Medical, Inc., 1993) and 1 other predicate after a 188-day review. Its family tree reaches back 2 generations to 1981. 4 later devices descend from it.
- Decided
- Oct 14, 1999
- Review
- 188 days
- Class
- Class U
- Product code
- MGP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K811291 (1981). 3 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK811291 Tegaderm Transparent Dressing3M Company · 1981
- 1 generation backK961319 EpiviewConvatec, A Division of E.R. Squibb & Sons · 1996
- This deviceK991214 Simplicare Transparent Wound DressingHollister, Inc. · 1999
- Descendant · cites it directly · 3 of its ownK020781 Wet ChamberKinetic Concepts, Inc. · 2002
- Descendant · 2 generations on · 1 of its ownK060046 DermastreamEnzysurge, Ltd. · 2006
- Descendant · 2 generations on · 0 of its ownK091133 Aplion Topical Care SystemAplion Medical,Llc · 2009
- Descendant · 2 generations on · 0 of its ownK043063 Oxyband Wound DressingOxyband Technologies, Inc. · 2005
Most influential descendants
Showing 4 of 4 · See all- K020781Wet ChamberKinetic Concepts, Inc. · 2002 · cites it directly3descendants
- K060046DermastreamEnzysurge, Ltd. · 2006 · 2 generations on1descendant
- K091133Aplion Topical Care SystemAplion Medical,Llc · 2009 · 2 generations on0descendants
- K043063Oxyband Wound DressingOxyband Technologies, Inc. · 2005 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K811291 | Tegaderm Transparent Dressing | 3M Company | 1981 | — |
| −1 | K961319 | Epiview | Convatec, A Division of E.R. Squibb & Sons | 1996 | — |
| 0 (this device) | K991214 | Simplicare Transparent Wound Dressing | Hollister, Inc. | 1999 | — |
| +1 | K020781 | Wet Chamber | Kinetic Concepts, Inc. | 2002 | — |
| +2 | K060046 | Dermastream | Enzysurge, Ltd. | 2006 | — |
| +2 | K091133 | Aplion Topical Care System | Aplion Medical,Llc | 2009 | — |
| +2 | K043063 | Oxyband Wound Dressing | Oxyband Technologies, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 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 MGP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K923235 | Bioclusive MVP Transparent DressingSummary page 1…Date Summary Prepared — July 8, 1999 2. Name of Device: Hollister SimpliCare Transparent Wound Dressing 3. Name of Predicate Device(s) Bioclusive Transparent Dressing, K923235 EpiVIEW Thin Film Dressing, K961319 4. Description of Device The Hollister SimpliCare Transparent Wound Dressing is a polyureth… | 1993 |
| * | K961319 | EpiviewSummary page 1…2. Name of Device: Hollister SimpliCare Transparent Wound Dressing 3. Name of Predicate Device(s) Bioclusive Transparent Dressing, K923235 EpiVIEW Thin Film Dressing, K961319 4. Description of Device The Hollister SimpliCare Transparent Wound Dressing is a polyurethane film that is backed with a press… | 1996 |
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 |
|---|---|---|---|
| K020781 | Wet Chamber | 2002 | 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?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 15.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K020781 (Kinetic Concepts, Inc., 2002) has gone furthest, with 3 descendants of its own.
How does its category compare?
All MGP devicesMGP Dressing, Wound And Burn, Occlusive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MGP
FDA has decided no MGP device since 2007.
Median 510(k) review, days · MGP
Too few MGP 510(k)s in any year since 2007 to give a median.
Recalls per year · MGP
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MGP
8in 2024
MAUDE reports naming product code MGP, 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 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 1 | 4 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 7 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 52 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SimpliCare Transparent Wound Dressing is intended to provide a moist wound healing environment to facilitate the normal wound healing process. The SimpliCare Transparent Wound Dressing provides a barrier to viral and bacterial contaminants and other external contaminates such as urine and feces. The SimpliCare Wound Dressing is also intended to be used on IV sites or as secondary fixation device for products such as alginates, gels and foam…
Read the full statement (152 words)
The SimpliCare Transparent Wound Dressing is intended to provide a moist wound healing environment to facilitate the normal wound healing process. The SimpliCare Transparent Wound Dressing provides a barrier to viral and bacterial contaminants and other external contaminates such as urine and feces. The SimpliCare Wound Dressing is also intended to be used on IV sites or as secondary fixation device for products such as alginates, gels and foam dressings.
The SimpliCare Transparent Wound Dressing is indicated for use on wounds including:
* minor burns and scalds
* superficial cuts, lacerations and abrasions
* minor irritations of the skin
This wound dressing may also be used for non-exudating to minimally exudating partial and full thickness wounds such as:
¢ pressure ulcers
e lacerations/abrasions
» surgical incisions
« second degree burns
¢ donor sites
In addition, the SimpliCare Transparent Wound Dressing can be used on IV sites and as a secondary fixation device
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/K991214 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991214: Simplicare Transparent Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991214
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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