Cleared Traditional

K253403 - FemVue® Controlled Saline-Air Device (FSA-300) (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K253403 · Femasys, Inc. · Obstetrics & Gynecology device
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Dec 2025
Decision
76d
Days
Class 2
Risk

K253403 is an FDA 510(k) clearance for the FemVue® Controlled Saline-Air Device (FSA-300). Classified as Cannula, Manipulator/injector, Uterine (product code LKF), Class II - Special Controls.

Submitted by Femasys, Inc. (Cumming, US). The FDA issued a Cleared decision on December 15, 2025 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Femasys, Inc. devices

Submission Details

510(k) Number K253403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2025
Decision Date December 15, 2025
Days to Decision 76 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
84d faster than avg
Panel avg: 160d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LKF Cannula, Manipulator/injector, Uterine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
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 Peers - LKF Cannula, Manipulator/injector, Uterine

All 86
Devices cleared under the same product code (LKF) and FDA review panel - the closest regulatory comparables to K253403.
RELIEEV HSG Catheter (HSG7FA1)
K252260 · Li Medical Corporation , Ltd. · Nov 2025
FemVue MINI Saline-Air Device
K242002 · Femasys, Inc. · Nov 2024
RELIEEV Uterine Manipulator Injector (CUMI 5.0)
K240364 · Li Medical Corporation , Ltd. · Oct 2024
FemChec Controlled Saline-Air Device (FCD-250)
K241693 · Femasys, Inc. · Sep 2024
Rejoni Intrauterine Catheter
K222798 · Rejoni, Inc. · Dec 2022
ALLY II Uterine Positioning System™ (UPS)
K223064 · CooperSurgical, Inc. · Oct 2022