510(k) · Cleared
ClearedBrady Medical Products Transcorbent and Thinsite Topical Border Wound Dressings
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brady Medical Products Co. · NAE Dressing, Wound, Hydrogel Without Drug And/Or Biologic
Cleared on Mar 1, 1995 after a 92-day review. FDA has not posted a summary or statement for it, so its predicates are not known.
- Decided
- Mar 1, 1995
- Review
- 92 days
- Class
- Class I
- Product code
- NAE
- Recalls
- None
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NAE? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
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 NAE devicesNAE Dressing, Wound, Hydrogel Without Drug And/Or Biologic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NAE
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · NAE
Too few NAE 510(k)s in any year since 2007 to give a median.
Recalls per year · NAE
2in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NAE
7in 2025
MAUDE reports naming product code NAE, 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 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 17 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 2 | 4 |
| 2019 | 0 | — | 0 | 8 |
| 2020 | 0 | — | 0 | 11 |
| 2021 | 0 | — | 0 | 15 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 13 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K945832 · printed Nov 6, 2026
Cite this page
510(k) Report. “K945832: Brady Medical Products Transcorbent and Thinsite Topical Border 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/K945832
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026