Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LKF · Predicate Candidate Screening
87 FDA 510(k) clearances under this product code; the 50 most recent screened below.
154 daysmedian FDA review time
418 days90th percentile
87clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253403 | FemVue® Controlled Saline-Air Device (FSA-300) | Femasys, Inc. | 2025-12-15 | 76 | 0 |
| K252260 | RELIEEV HSG Catheter (HSG7FA1) | Li Medical Corporation , Ltd. | 2025-11-26 | 128 | 0 |
| K242002 | FemVue MINI Saline-Air Device | Femasys, Inc. | 2024-11-22 | 136 | 0 |
| K240364 | RELIEEV Uterine Manipulator Injector (CUMI 5.0) | Li Medical Corporation , Ltd. | 2024-10-16 | 253 | 0 |
| K241693 | FemChec Controlled Saline-Air Device (FCD-250) | Femasys, Inc. | 2024-09-06 | 86 | 0 |
| K222798 | Rejoni Intrauterine Catheter | Rejoni, Inc. | 2022-12-16 | 91 | 0 |
| K223064 | ALLY II Uterine Positioning System™ (UPS) | CooperSurgical, Inc. | 2022-10-28 | 28 | 0 |
| K220202 | Uterine ElevatOR PRO with OccludOR Balloon | The O R Company Pty, Ltd. | 2022-03-31 | 66 | 0 |
| K212505 | DUMI ManipulatOR | The O R Company Pty, Ltd. | 2022-01-10 | 154 | 0 |
| K181770 | Intrauterine Access Balloon Catheter, Selective Salpingograp | Cook Incorporated | 2019-03-29 | 269 | 0 |
| K180300 | Margolin HSG Cannula, Goldstein Sonohysterography Catheter | Cook Incorporated | 2018-10-26 | 266 | 0 |
| K180291 | Cook Silicone Balloon HSG Catheter | Cook Incorporated | 2018-10-26 | 267 | 0 |
| K172846 | Uterine Manipulator | Beijing Hangtian Kadi Technology R&D Institute | 2018-06-26 | 280 | 0 |
| K171604 | Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian | Cook Incorporated | 2018-02-15 | 259 | 0 |
| K163214 | Unicare System, Unicare Manipulator | Clearpath Surgical, Inc. | 2017-02-07 | 83 | 0 |
| K160217 | uVue HSG/SHG Catheter | Cook Incorporated | 2016-10-06 | 251 | 0 |
| K153092 | Ally Uterine Positioning System | CooperSurgical, Inc. | 2015-12-21 | 56 | 0 |
| K150519 | ManipulatOR PRO, ManipulatOR | Gynetech Pty. , Ltd. | 2015-08-19 | 170 | 0 |
| K142545 | SonoFlow Sonohysterography and Sonohysterosalpingography Dev | Crossbay Medical, Inc. | 2015-03-20 | 191 | 0 |
| K143415 | Air Bubble Based Infuser (ABBI) | CooperSurgical, Inc. | 2015-02-26 | 90 | 0 |
| K142716 | VCARE | Conmed Corporation | 2015-02-10 | 140 | 0 |
| K142164 | MANIPULATOR; MANIPULATOR PRO | Gynetech Pty. , Ltd. | 2014-12-17 | 133 | 0 |
| K141523 | ALLY UPS | CooperSurgical, Inc. | 2014-11-25 | 169 | 1 |
| K131781 | CLEARVIEW TOTAL | Clinical Innovations, LLC | 2014-05-28 | 345 | 0 |
| K130758 | KRONNER SIDE-KICK UTERINE MANIPULATOR HOLDER | Kronner Prototypes, Inc. | 2013-12-11 | 266 | 0 |
| K122820 | VIKY UP | Endocontrol | 2013-06-18 | 277 | 0 |
| K123258 | THE ADVANCE CATHETER FOR HSG AND SIS | Catheter Research, Inc. | 2013-01-31 | 105 | 0 |
| K102898 | BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLO | Panpac Medical Corporation | 2011-12-15 | 441 | 0 |
| K110993 | FEMCHEC PRESSURE MANAGEMET DEVICE | Femasys, Inc. | 2011-10-12 | 187 | 0 |
| K110288 | FEMVUE SALINE-AIR DEVICE | Femasys, Inc. | 2011-04-28 | 86 | 0 |
| K092983 | PANPAC HSG CATHETER SET | Panpac Medical Corporation | 2010-06-07 | 252 | 0 |
| K092969 | H/S CATHETER SET 5 FRENCH, MODEL 61-5005F, H/S CATHETER SET | Sterling Medical, Inc. | 2010-04-30 | 217 | 0 |
| K100662 | FEMVUE CORNUAL BALLOON CATHETER | Femasys, Inc. | 2010-04-07 | 30 | 0 |
| K092984 | PANPAC UTERINE INECTOR, MODEL UI-4.0, UI-2.0 | Panpac Medical Corporation | 2010-04-07 | 191 | 0 |
| K093556 | VCARE DX | Conmed Corporation | 2010-03-12 | 115 | 0 |
| K092980 | PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5 | Panpac Medical Corporation | 2010-03-11 | 164 | 0 |
| K083594 | EZ HSG CATHETER.FOAMSEAL CATHETER | Obg Products | 2009-07-21 | 228 | 0 |
| K083690 | FEMVUE(TM) CATHETER SYSTEM | Femasys, Inc. | 2009-06-23 | 193 | 0 |
| K071405 | PROBE HOLDER SYSTEM | Intuitive Surgical, Inc. | 2007-10-09 | 141 | 0 |
| K071907 | VCARE RETRACTOR/ELEVATOR | Conmed Corporation | 2007-10-05 | 87 | 4 |
| K063611 | SALINE/ CONTRAST MEDIA INFUSION CATHETER | Utah Medical Products, Inc. | 2007-05-23 | 171 | 0 |
| K061679 | WALLACE ARTIFICIAL INSEMINATION CATHETER | Irvine Scientific Sales Co., Inc. | 2006-10-13 | 120 | 0 |
| K041062 | INTRAUTERINE VENOGRAM NEEDLE SET | Cook Urological, Inc. | 2004-10-01 | 161 | 0 |
| K040238 | SOFTSEAL HSG CATHETER | Modern Medical Equipment Mfg., Ltd. | 2004-06-22 | 148 | 0 |
| K041094 | HSG CATHETER SET | Bioteque America, Inc. | 2004-06-17 | 51 | 0 |
| K032835 | H/S CATHETER SET | Catheter Research, Inc. | 2003-12-11 | 91 | 1 |
| K023051 | INTRAUTERINE DELIVERY SYSTEM - INJECTOR | Prosurg, Inc. | 2002-12-12 | 90 | 0 |
| K022503 | UTERINE INJECTOR | Thomas Medical, Inc. | 2002-10-25 | 88 | 0 |
| K021272 | SIB CATHETER, MODEL 61-7005 | Ackrad Laboratories | 2002-05-21 | 29 | 0 |
| K020954 | H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPT | Ackrad Laboratories | 2002-04-24 | 30 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda