FemVue® Controlled Saline-Air Device (FSA-300)
FDA 510(k) K253403 · Femasys, Inc.
510(k) numberK253403
Submission
- Device name
- FemVue® Controlled Saline-Air Device (FSA-300)
- Applicant
- Femasys, Inc.
Cumming, GA, US - Received
- September 30, 2025
- Decision date
- December 15, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LKF – Cannula, Manipulator/Injector, Uterine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4530
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code LKF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252260 | RELIEEV HSG Catheter (HSG7FA1)LKF · Traditional | Li Medical Corporation , Ltd. | 11/26/2025SE |
| K242002 | FemVue MINI Saline-Air DeviceLKF · Traditional | Femasys, Inc. | 11/22/2024SE |
| K240364 | RELIEEV Uterine Manipulator Injector (CUMI 5.0)LKF · Traditional | Li Medical Corporation , Ltd. | 10/16/2024SE |
| K241693 | FemChec Controlled Saline-Air Device (FCD-250)LKF · Traditional | Femasys, Inc. | 09/06/2024SE |
| K222798 | Rejoni Intrauterine CatheterLKF · Traditional | Rejoni, Inc. | 12/16/2022SE |
| K223064 | ALLY II Uterine Positioning System (UPS)LKF · Special | CooperSurgical, Inc. | 10/28/2022SE |
| K220202 | Uterine ElevatOR PRO with OccludOR BalloonLKF · Traditional | The O R Company Pty, Ltd. | 03/31/2022SE |
| K212505 | DUMI ManipulatORLKF · Traditional | The O R Company Pty, Ltd. | 01/10/2022SE |
| K181770 | Intrauterine Access Balloon Catheter, Selective Salpingography CatheterLKF · Traditional | Cook Incorporated | 03/29/2019SE |
| K180300 | Margolin HSG Cannula, Goldstein Sonohysterography CatheterLKF · Traditional | Cook Incorporated | 10/26/2018SE |
More from Cook Incorporated
| 510(k) | Device | Decision |
|---|---|---|
| K242002 | FemVue MINI Saline-Air DeviceLKF · Traditional | 11/22/2024SE |
| K241693 | FemChec Controlled Saline-Air Device (FCD-250)LKF · Traditional | 09/06/2024SE |
| K231730 | FemaSeed Intratubal InseminationMQF · Traditional | 09/22/2023SE |
| K122658 | Femcerv Endocervical Sampler Model 3 Sizes: Ref FCV-013, Ref FCV-011, Ref FCV-009PCF · Traditional | 12/20/2012SE |
| K110993 | Femchec Pressure Managemet DeviceLKF · Traditional | 10/12/2011SE |
| K110288 | Femvue Saline-Air DeviceLKF · Traditional | 04/28/2011SE |
| K100662 | Femvue Cornual Balloon CatheterLKF · Special | 04/07/2010SE |
| K083690 | Femvue(Tm) Catheter SystemLKF · Traditional | 06/23/2009SE |
Questions and answers
When was FemVue® Controlled Saline-Air Device (FSA-300) cleared by the FDA?
FemVue® Controlled Saline-Air Device (FSA-300) (K253403) received a 510(k) decision of Substantially Equivalent on December 15, 2025, 76 days after the submission was received.
What is the product code of K253403?
The FDA product code is LKF – Cannula, Manipulator/Injector, Uterine, a Class II (moderate risk) device regulated under 21 CFR 884.4530.