K253662 is the FDA 510(k) clearance record for LIXI (LXOSFM1), a class II device, cleared for Luwi, LLC on 2026-07-14 under FDA product code MSC (Barrier, Std, Oral Sex). FDA records list one 510(k) clearance for Luwi, LLC. As of 2026-09-10 , FDA records show no recalls naming K253662.
Clearance record Decision date 2026-07-14 Received 2025-11-20 (236 days to decision) Product code MSC Barrier, Std, Oral SexRegulation 21 CFR 884.5300 Device class Class II Review panel Obstetrics/Gynecology Applicant Luwi, LLC 148 Randhurst Village Dr., Mount Prospect IL 510(k) summary Summary PDF ↗ Third party review No
Clearances, product code MSC Trailing 12 months 1 clearance under product code MSC in the twelve months to October 2026, July 2026 the highest month at 1. Show the numbers FIRST ARTICLE / WEEKLY
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Product code MSC
FDA records show no recalls under product code MSC.
MDM coverage of this record lists here, newest first.
About this record Sourced from the FDA 510(k) premarket notification database, ingested from openFDA. MDM adds the decision time in days, the product code cross-link, recalls sharing that product code, and MDM coverage of the record.
Predicate devices are not listed. The openFDA 510(k) endpoint does not publish predicate references, so MDM does not assert them. Where a 510(k) summary exists, the FDA PDF is linked above and names the predicate itself.
Data as of 2026-09-28 , the FDA export date for this dataset. Page last changed 2026-09-05 . View this record on fda.gov ↗ (opens on fda.gov)
