Atlas FDA

MQF

53 FDA 510(k) clearances · Product code

135 daysmedian time to decision
266 days90th percentile
53clearances measured

FDA profile

Official device name
Catheter, Assisted Reproduction
Device class
Class II (moderate risk)
Regulation
21 CFR 884.6110
Medical specialty
Obstetrics/Gynecology
Flags
Third-party review eligible
Adverse events (MAUDE)
2017: 10 · 2018: 27 · 2019: 16 · 2020: 19 · 2021: 13 · 2026: 14
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C) (K253354)Guangzhou Hehong Biotech Co., Ltd.2026-02-12
Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet - 180 mm (REF 17510); EmbryoCath Stylet - 230 mm (REF 17511) (K243373)Vitrolife Sweden AB2025-07-23
VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH) (K240307)Shenzhen Vitavitro Biotech Co., Ltd.2024-08-16
FemaSeed Intratubal Insemination (K231730)Femasys, Inc.2023-09-22
Daylily Single Use Sterile Embryo Transfer Catheter (K220010)Shanghai Horizon Medical Technology Co., Ltd.2022-12-16
Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators (K200248)Allwin Medical Devices, Inc.2020-07-01
Kitazato ET Catheters (K192540)Kitazato Corporation2020-05-01
Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra Uterine Insemination Catheter, CURVED and CURVED Open Tip Intra Uterine Insemination Catheter, TRACKABLE and TRACKABLE Open Tip Intra Uterine Insemination Catheter, FLEXI and FLEXI Open Tip Intra Uterine Insemination Catheter, STUMPY Intra Uterine Insemination Catheter) (K190522)Allwin Medical Devices, Inc.2019-11-14
Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Transfer Catheter Set with Echogenic Tip) (K191015)Cook Incorporated2019-05-17
Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable Obturator, Guardia™ ETS Embryo-Tested Syringe, Flushing Catheter (K180302)Cook Incorporated2018-10-24
Towako Transmyometrial Embryo Transfer Set (K173431)William A. Cook Australia Pty. , Ltd.2018-05-18
Pivet and Soft-Pass Embryo Transfer Catheter Sets (K173103)Cook Incorporated2018-04-13
Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter (K173686)Cook Incorporated2018-04-11
Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter (K172051)Cook Incorporated2018-01-10
Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters (K172321)Cook Incorporated2017-12-21
Soules Intrauterine Insemination Catheter (K163318)Cook Incorporated2017-07-14
Kitazato ET Catheters (K162878)Kitazato Corporation2017-07-13
Kitazato IUI Catheter (K162667)Kitazato Corporation2017-05-11
Transem and EchoGen Embryo Transfer Catheters (K161547)Origio A/S2017-03-09
CrossBay IVF Embryo Transfer Catheter Set (K162064)Crossbay Medical, Inc.2017-01-05
MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI Catheter (K143669)Medgyn Products, Inc.2015-11-23
FERTILIGENT SLOW RELEASE IUI CATHETER KIT (K141666)Fertiligent, Ltd.2015-02-03
KITAZATO IUI CATHETER (K131491)Kitazato Medical Co., Ltd.2013-09-11
IUI CATHETERS (K112396)Kitazato Medical Co., Ltd.2012-11-02
INTRAUTERINE INSEMINATION (IUI) CATHETER (K120154)Catheter Research, Inc.2012-03-21
INTRAUTERINE INSEMINATION (IUI) CATHETER (K092579)Fertiligent, Ltd.2010-04-02
CLEAR VISION EMBRYO TRANSFER CATHETER SET, MODEL B100000 - B 100007; CLEAR VISION TRIAL TRANSFER CATHETER SET (K053208)Swemed Lab International AB2006-01-30
IUI CATHETER, MODEL 9057 (K052059)Inntec, Inc.2005-11-22
EMBRYO TRANSFER CATHETER WITH ACCESSORY STYLET, MODELS 9018, 9023, 9018-S, 9023-S (K050521)Inntec, Inc.2005-05-02
MORTON IUI CATHETERS (K041470)Fertility Technology Resources, Inc.2004-11-22
WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETER (K033084)Portex , Ltd.2003-12-19
COOPERSURGICAL MALLEABLE SYTLET (K023382)Cooper Surgical2002-12-20
TUCKER EMBRYO CATHETER (K023017)Fertility Technology Resources, Inc.2002-12-13
COOPERSURGICAL TRIAL TRANSFER CATHETER (K023384)Cooper Surgical2002-12-13
COOPERSURGICAL INTRAUTERINE INSEMINATION CATHETER (K023383)Cooper Surgical2002-12-13
COOPERSURGICAL EMBRYO TRANSFER CATHETER, COOPERSURGICAL ASSISTED REPRODUCTION CATHETER (K023379)Cooper Surgical2002-12-11
EMTRAC; DELPHIN; SEMTRAC 2000 SET (K013536)Gynetics Medical Products NV2001-11-30
IUI, MODEL 4220; SMOOZE, MODEL 4225, L; SEMINOR, MODEL 4502 A, B (K013501)Gynetics Medical Products NV2001-11-30
TAO EMBRYO TRANSFER CATHETER SYSTEM (K012220)Ttj Biomedical, LLC2001-08-27
EMBRYO TRANSFER CATHETER SET, MODEL 320200 AND 320201 (K000950)Labotect Labor-Technik Gottingen2000-05-12
EMBRYON GIFT TRANSFER CATHETERS/SETS (K000656)Rocket Medical Plc2000-03-09
EMBRYON TRANSFER CATHETERS/SETS (K994327)Rocket Medical Plc2000-02-28
EMBRYO GLIDE EMBRYO TRANSFER CATHETER, EMBRYO GLIDE STYLE FOR EMBRYO TRANSFER CATHETER (K992307)Fertility Technology Resources, Inc.1999-09-13
<GENX> EMBRYO TRANSFER CATHETER CC GLIDER (K991266)<Genx> Intl., Inc.1999-09-09
WALLACE TRIAL TRANSFER CATHETER, MODEL TT 1816N (K990348)CooperSurgical, Inc.1999-07-26
WALLACE MALLEABLE STYLET-18CM, MODEL 1816ST, WALLACE MALLEABLE STYLET-23CM, MODEL 1816NST (K990349)CooperSurgical, Inc.1999-07-26
WALLACE CATHETERS-18CM, MODEL 1816; 23CM, MODEL 1816N; 23CM, MODEL 2316 (K990350)CooperSurgical, Inc.1999-07-26
INTRA-UTERINE TRANSFER, INTRA-FOLOPIAN TRANSFER (K983604)Washington Regulatory Services1999-05-27
TRANSMYOMETRIAL EMBRYO TRANSFER SET (K983595)Cook Ob/Gyn1999-02-08
EMBRYO TRANSFER CATHETERS/SETS (K983594)Cook Ob/Gyn1998-12-21
INTRATUBAL TRANSFER SETS (K983591)Cook Ob/Gyn1998-12-21
GIFT CATHETER SET/S (K983590)Cook Ob/Gyn1998-12-21
HYSTEROSCOPIC GIFT CATHETER SETS (K983587)Cook Ob/Gyn1998-12-16

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Every clearance here is in the API, with alerts when new ones post.