510(k) · Cleared
Recalled · Class II · 2013Omed Wound Closure Strips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oxboro Medical Intl., Inc. · FPX Strip, Adhesive, Closure, Skin
Cleared on Jan 29, 1988 after a 66-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled once.
- Decided
- Jan 29, 1988
- Review
- 66 days
- Class
- Class I
- Product code
- FPX
- Recalls
- 1
- 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 FPX? 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 18, 2013 | Class II | Z-1988-2013 | Process design | Aspen Surgical is recalling Wound Closures because firm could not confirm sterility, after FDA sampling indicated the product may not be sterile. Using the recalled product could lead to infection which may require further treatment… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All FPX devicesFPX Strip, Adhesive, Closure, Skin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FPX
FDA has decided no FPX device since 2007.
Median 510(k) review, days · FPX
Too few FPX 510(k)s in any year since 2007 to give a median.
Recalls per year · FPX
No recall names FPX since 2007.
Adverse event reports per year · FPX
10in 2021
MAUDE reports naming product code FPX, 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 | 6 |
| 2010 | 0 | — | 0 | 10 |
| 2011 | 0 | — | 0 | 8 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 9 |
| 2021 | 0 | — | 0 | 10 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K874813 · printed Nov 4, 2026
Cite this page
510(k) Report. “K874813: Omed Wound Closure Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K874813
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026