510(k) · Cleared
ClearedLixi (LXOSFM1)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Luwi, LLC · MSC Barrier, Std, Oral Sex
Cleared on Jul 14, 2026 as substantially equivalent to K212928 (Brazen Goods Inc. Dba Lorals, 2022) after a 236-day review. Its family tree reaches back 3 generations to 1999.
- Decided
- Jul 14, 2026
- Review
- 236 days
- Class
- Class II
- Product code
- MSC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K990067 (1999). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 MSC? 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 MSC device
- #1 K212928 Loralsscore 6.5 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K212928 | LoralsSummary page 5…MSC (Barrier, Std, Oral Sex) III. Legally Marketed Predicate Devices 510(k) Trade Name Product Code K212928 Lorals MSC The predicate device has not been subject to a design related… | 2022 |
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?
- The line of descent spans 27 years and passes through 4 companies; a new generation was cleared every 11.0 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All MSC devicesMSC Barrier, Std, Oral Sex: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · MSC
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · MSC
Too few MSC 510(k)s in any year since 2007 to give a median.
Recalls per year · MSC
No recall names MSC since 2007.
Adverse event reports per year · MSC
No MAUDE report names MSC since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
LIXI (Ixosfm1) are used as a barrier when engaging in oral/vaginal and oral/anal sex to help reduce the transmission of bodily fluids, harmful pathogens, and sexually transmitted infections.
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/K253662 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253662: Lixi (LXOSFM1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253662
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026