510(k) · Cleared
ClearedCenturion Sorbaview Otc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tri-State Hospital Supply Corp. · NAD Dressing, Wound, Occlusive
Cleared on Apr 23, 2008 as substantially equivalent to K945977 (Tri-State Hospital Supply Corp., 1995) and 1 other predicate after a 57-day review. Its family tree reaches back 1 generation to 1981.
- Decided
- Apr 23, 2008
- Review
- 57 days
- Class
- Class I
- Product code
- NAD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K811291 (1981). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK811291 Tegaderm Transparent Dressing3M Company · 1981
- This deviceK080524 Centurion Sorbaview OtcTri-State Hospital Supply Corp. · 2008
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) | K080524 | Centurion Sorbaview Otc | Tri-State Hospital Supply Corp. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 |
|---|---|---|---|
| * | K945977 | Centurion (R) Site Guard (R) Transparent Dressing/Transpaent Film DressingSummary page 1…cate SE Device(s): This product is similar in design, composition, function, and method of use to the following products: * Centurion® SiteGuard® Transparent Dressing (K945 977) • 3M Tegaderm~m + Pad (K81 1291) Description: SorbaView® dressings are highly permeable, self-adhesive, transparent film dress… | 1995 |
| * | K811291 | Tegaderm Transparent DressingSummary page 1…similar in design, composition, function, and method of use to the following products: * Centurion® SiteGuard® Transparent Dressing (K945 977) • 3M Tegaderm~m + Pad (K81 1291) Description: SorbaView® dressings are highly permeable, self-adhesive, transparent film dressings that are of multi-layer constr… | 1981 |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All NAD devicesNAD Dressing, Wound, Occlusive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
Centurion® SorbaView® OTC dressings are intended for medical purposes to cover and protect wounds, hold together the skin edges of a wound, support an injured part of the body, or to secure objects to the skin.
This device is intended for lay or prescription use by pediatric or adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080524 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080524: Centurion Sorbaview Otc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080524
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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