510(k) · Cleared
ClearedEpiview
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Convatec, A Division of E.R. Squibb & Sons · MGP Dressing, Wound And Burn, Occlusive
Cleared on Jul 8, 1996 as substantially equivalent to K811291 (3M Company, 1981) after a 94-day review. Its family tree reaches back 1 generation to 1981. 5 later devices descend from it.
- Decided
- Jul 8, 1996
- Review
- 94 days
- Class
- Class U
- Product code
- MGP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K811291 (1981). 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK811291 Tegaderm Transparent Dressing3M Company · 1981
- This deviceK961319 EpiviewConvatec, A Division of E.R. Squibb & Sons · 1996
- Descendant · cites it directly · 4 of its ownK991214 Simplicare Transparent Wound DressingHollister, Inc. · 1999
- Descendant · 2 generations on · 3 of its ownK020781 Wet ChamberKinetic Concepts, Inc. · 2002
- Descendant · 3 generations on · 1 of its ownK060046 DermastreamEnzysurge, Ltd. · 2006
- Descendant · 3 generations on · 0 of its ownK091133 Aplion Topical Care SystemAplion Medical,Llc · 2009
- Descendant · 3 generations on · 0 of its ownK043063 Oxyband Wound DressingOxyband Technologies, Inc. · 2005
Most influential descendants
Showing 5 of 5 · See all- K991214Simplicare Transparent Wound DressingHollister, Inc. · 1999 · cites it directly4descendants
- K020781Wet ChamberKinetic Concepts, Inc. · 2002 · 2 generations on3descendants
- K060046DermastreamEnzysurge, Ltd. · 2006 · 3 generations on1descendant
- K091133Aplion Topical Care SystemAplion Medical,Llc · 2009 · 3 generations on0descendants
- K043063Oxyband Wound DressingOxyband Technologies, Inc. · 2005 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K811291 | Tegaderm Transparent Dressing | 3M Company | 1981 | — |
| 0 (this device) | K961319 | Epiview | Convatec, A Division of E.R. Squibb & Sons | 1996 | — |
| +1 | K991214 | Simplicare Transparent Wound Dressing | Hollister, Inc. | 1999 | — |
| +2 | K020781 | Wet Chamber | Kinetic Concepts, Inc. | 2002 | — |
| +3 | K060046 | Dermastream | Enzysurge, Ltd. | 2006 | — |
| +3 | K091133 | Aplion Topical Care System | Aplion Medical,Llc | 2009 | — |
| +3 | K043063 | Oxyband Wound Dressing | Oxyband Technologies, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K811291 | Tegaderm Transparent DressingSummary page 1…, or over arterial sites. The dressing is not intended to replace sutures. EpiVIEW Thin Film Dressing is substantially equivalent to 3M's Tegaderm Transparent Dressing, K811291. Both devices have essentially the same intended uses, contraindications, precautions and observations. EpiVIEW Thin Film Dressin… | 1981 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991214 | Simplicare Transparent Wound Dressing | 1999 | 4 |
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?
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?
EpiVIEW Thin Film Dressing is indicated as a securement device and dressing for peripheral and central IV catheters. It may be used as a wound dressing on minor abrasions, superficial pressure ulcers, over eschar to facilitate debridement, skin graft donor sites, closed clean surgical wounds and first and second degree burns. EpiVIEW may also be used to prevent skin breakdown from chating or from exposure to continuous moisture and friction .
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/K961319 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961319: Epiview.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961319
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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