Cleared Traditional

K253662 - LIXI (LXOSFM1)

K253662 is an FDA 510(k) clearance for LIXI (LXOSFM1), manufactured by Luwi, LLC. The device is a Class 2 Obstetrics & Gynecology device with product code MSC cleared through the Traditional 510(k) pathway after a 236-day FDA review.

K253662 · Luwi, LLC · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
236d
Days
Class 2
Risk

K253662 is an FDA 510(k) clearance for the LIXI (LXOSFM1). Classified as Barrier, Std, Oral Sex (product code MSC), Class II - Special Controls.

Submitted by Luwi, LLC (Mount Prospect, US). The FDA issued a Cleared decision on July 14, 2026 after a review of 236 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5300 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Luwi, LLC devices

FDA 510(k) Submission Details - K253662

510(k) Number K253662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2025
Decision Date July 14, 2026
Days to Decision 236 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 160d · This submission: 236d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MSC Device Classification - Class 2, Special Controls

Product Code MSC Barrier, Std, Oral Sex
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Consultant

Rook Quality Systems
Tyler Ting

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MSC Barrier, Std, Oral Sex

Devices cleared under the same product code (MSC) and FDA review panel - the closest regulatory comparables to K253662.
Lorals
K212928 · Brazen Goods Inc. Dba Lorals · Apr 2022
SancDam Latex Oral Dam
K212037 · Sanctuary Health Sdn. Bhd. · Mar 2022
Harmony Latex Dam, Harmony Non-Latex Dam
K203727 · Pamco Distributing, Inc. · Aug 2021
SHEER GLYDE DAMS
K990067 · Louise C. Myers · Feb 1999
GLYDE DAM LOLLYES
K970577 · Glyde USA, Inc. · Jan 1998