LKF · Class II · 21 CFR 884.4530

FDA Product Code LKF: Cannula, Manipulator/injector, Uterine

Leading manufacturers include Femasys, Inc., Ackrad Laboratories and Cook Incorporated.

87
Total
87
Cleared
194d
Avg days
1978
Since
Stable submission activity - 3 submissions in the last 2 years
Review times improving: avg 113d recently vs 197d historically

FDA 510(k) Cleared Cannula, Manipulator/injector, Uterine Devices (Product Code LKF)

87 devices
1–24 of 87
Cleared Dec 15, 2025
FemVue® Controlled Saline-Air Device (FSA-300)
K253403
Femasys, Inc.
Obstetrics & Gynecology · 76d
Cleared Nov 26, 2025
RELIEEV HSG Catheter (HSG7FA1)
K252260
Li Medical Corporation , Ltd.
Obstetrics & Gynecology · 128d
Cleared Nov 22, 2024
FemVue MINI Saline-Air Device
K242002
Femasys, Inc.
Obstetrics & Gynecology · 136d
Cleared Oct 16, 2024
RELIEEV Uterine Manipulator Injector (CUMI 5.0)
K240364
Li Medical Corporation , Ltd.
Obstetrics & Gynecology · 253d
Cleared Sep 06, 2024
FemChec Controlled Saline-Air Device (FCD-250)
K241693
Femasys, Inc.
Obstetrics & Gynecology · 86d
Cleared Dec 16, 2022
Rejoni Intrauterine Catheter
K222798
Rejoni, Inc.
Obstetrics & Gynecology · 91d
Cleared Oct 28, 2022
ALLY II Uterine Positioning System™ (UPS)
K223064
CooperSurgical, Inc.
Obstetrics & Gynecology · 28d
Cleared Mar 31, 2022
Uterine ElevatOR PRO with OccludOR Balloon
K220202
The O R Company Pty, Ltd.
Obstetrics & Gynecology · 66d
Cleared Jan 10, 2022
DUMI ManipulatOR
K212505
The O R Company Pty, Ltd.
Obstetrics & Gynecology · 154d
Cleared Mar 29, 2019
Intrauterine Access Balloon Catheter, Selective Salpingography Catheter
K181770
Cook Incorporated
Obstetrics & Gynecology · 269d
Cleared Oct 26, 2018
Cook Silicone Balloon HSG Catheter
K180291
Cook Incorporated
Obstetrics & Gynecology · 267d
Cleared Oct 26, 2018
Margolin HSG Cannula, Goldstein Sonohysterography Catheter
K180300
Cook Incorporated
Obstetrics & Gynecology · 266d
Cleared Jun 26, 2018
Uterine Manipulator
K172846
Beijing Hangtian Kadi Technology R&D Institute
Obstetrics & Gynecology · 280d
Cleared Feb 15, 2018
Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set, and Fallopian Tube Catheterization Wire Guide with Platinum Tip
K171604
Cook Incorporated
Obstetrics & Gynecology · 259d
Cleared Feb 07, 2017
Unicare System, Unicare Manipulator
K163214
Clearpath Surgical, Inc.
Obstetrics & Gynecology · 83d
Cleared Oct 06, 2016
uVue HSG/SHG Catheter
K160217
Cook Incorporated
Obstetrics & Gynecology · 251d
Cleared Dec 21, 2015
Ally Uterine Positioning System
K153092
CooperSurgical, Inc.
Obstetrics & Gynecology · 56d
Cleared Aug 19, 2015
ManipulatOR PRO, ManipulatOR
K150519
Gynetech Pty. , Ltd.
Obstetrics & Gynecology · 170d
Cleared Mar 20, 2015
SonoFlow Sonohysterography and Sonohysterosalpingography Device
K142545
Crossbay Medical, Inc.
Obstetrics & Gynecology · 191d
Cleared Feb 26, 2015
Air Bubble Based Infuser (ABBI)
K143415
CooperSurgical, Inc.
Obstetrics & Gynecology · 90d
Cleared Feb 10, 2015
VCARE
K142716
Conmed Corporation
Obstetrics & Gynecology · 140d
Cleared Dec 17, 2014
MANIPULATOR
K142164
Gynetech Pty. , Ltd.
Obstetrics & Gynecology · 133d
Cleared Nov 25, 2014
ALLY UPS
K141523
CooperSurgical, Inc.
Obstetrics & Gynecology · 169d
Cleared May 28, 2014
CLEARVIEW TOTAL
K131781
Clinical Innovations, LLC
Obstetrics & Gynecology · 345d

About Product Code LKF - Regulatory Context

510(k) Submission Activity

87 total 510(k) submissions under product code LKF since 1978, with 87 receiving FDA clearance (average review time: 194 days).

Submission volume has remained relatively stable over the observed period, with 3 submissions in the last 24 months.

FDA 510(k) Review Time - LKF Product Code

Recent submissions under LKF have taken an average of 113 days to reach a decision - down from 197 days historically, suggesting improved FDA processing for this classification.

LKF devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →