510(k) · Decided
DecidedSimplicare Thin Film Wound Dressings
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 Feb 20, 1998 after a 31-day review. The FDA summary names its predicate without a number.
- Decided
- Feb 20, 1998
- Review
- 31 days
- Class
- Class U
- Product code
- MGP
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 |
|---|---|---|---|
| * | — | Innovative Technologies Transparent Thin Film Wound Dressing Named without a submission number | |
| * | — | Innovative Technologies Intelligent Thin Film Wound Dressing Named without a submission number |
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.
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 Hollister Thin Film Wound Dressings are intended to provide a moist wound healing environment to facilitate the normal wound healing process. The Hollister Thin Film Wound Dressings provide a barrier to bacteria and external contaminates such as urine and feces. The Hollister Thin Film Wound Dressings are also intended to be used on IV sites or as secondary fixation devices for products such as alginates, gels and foam dressings used for venous…
Read the full statement (124 words)
The Hollister Thin Film Wound Dressings are intended to provide a moist wound healing environment to facilitate the normal wound healing process. The Hollister Thin Film Wound Dressings provide a barrier to bacteria and external contaminates such as urine and feces. The Hollister Thin Film Wound Dressings are also intended to be used on IV sites or as secondary fixation devices for products such as alginates, gels and foam dressings used for venous stasis and diabetic ulcers.
OTC:
minor burns
superficial cuts, lacerations and abrasions
minor irritations of the skin
Under the care of a health care professional:
non-exuding to minimally exuding wounds
pressure sores
lacerations/abrasions
partial and full thickness wounds
post-operative surgical wounds
second degree burns
donor sites
IV sites
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/K980209 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980209: Simplicare Thin Film Wound Dressings.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980209
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026