Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
MQK — Predicate Candidate Screening
50 FDA 510(k) clearances under this product code; the 50 most recent screened below.
164 daysmedian FDA review time
326 days90th percentile
50clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241626 | SperSort™ Sperm Sorting Chip (IPG02) | Ipreg Incorporation | 2025-02-20 | 259 | 0 |
| K241454 | Minvitro® Vitrification Straw (MVT-VSN series, including MVT | Guangzhou Hehong Biotech Co., Ltd. | 2025-02-03 | 257 | 0 |
| K241348 | SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) | Motilitycount Aps | 2025-01-31 | 263 | 0 |
| K241341 | cryo-GO Vitrification Device | Fujifilm Irvine Scientific | 2024-09-26 | 136 | 0 |
| K240002 | G-Vitri™ Vitrification Straw | Gimbo Medical Technology Shenzhen Co., Ltd. | 2024-06-14 | 164 | 0 |
| K232980 | SpermAlign Sperm Separation Device | Cytoswim, Ltd. | 2024-03-14 | 175 | 0 |
| K233177 | Nest VT Vitrification Device | Cook Incorporated | 2024-03-08 | 162 | 0 |
| K221810 | LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm S | Bonraybio Co., Ltd. | 2022-10-31 | 131 | 0 |
| K213869 | EmbryoSlide+ ic8 dish | Vitrolife A/S | 2022-03-11 | 88 | 0 |
| K203626 | SureStrip Vitrification Straw, SureLock Vitrification Straw | Allwin Medical Devices, Inc. | 2021-06-04 | 175 | 0 |
| K201213 | Pasteur Pipette 3mL, Pasteur Pipette 1mL | Hertart Aps | 2020-12-16 | 225 | 0 |
| K200815 | VitriGuard | Origio A/S | 2020-06-25 | 87 | 0 |
| K181461 | Rapid-i™ Kit | Vitrolife Sweden AB | 2019-01-04 | 214 | 0 |
| K181469 | Cryotop®US-flash and Cryotop®US-scoop | Kitazato Corporation | 2018-11-09 | 158 | 0 |
| K180740 | VitriGuard | Origio A/S | 2018-05-04 | 43 | 0 |
| K173075 | ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separa | Dxnow, Inc. | 2018-03-08 | 160 | 0 |
| K172751 | iVitri Straw | Reprobitech Corp. | 2018-02-09 | 150 | 0 |
| K162640 | iVitri EZ | Reprobitech Corp. | 2017-06-30 | 281 | 0 |
| K162833 | VitriGuard | Origio A/S | 2017-02-16 | 128 | 0 |
| K162051 | Cryotec | Reprolife, Inc. | 2016-12-14 | 142 | 0 |
| K153027 | Cryotop US | Kitazato Biopharma Co., Ltd. | 2016-03-14 | 150 | 0 |
| K150961 | EmbryoSlide Culture Dish | Vitrolife A/S | 2015-12-04 | 238 | 0 |
| K150756 | Micro well group culture dish, 9-well; Micro well group cult | Hertart | 2015-07-20 | 119 | 0 |
| K140207 | RAPID-I KIT | Vitrolife Sweden AB | 2014-12-18 | 324 | 0 |
| K141663 | EEVA DISH (WITH 12 MICROWELLS) | Auxogyn, Inc. | 2014-07-22 | 29 | 0 |
| K133295 | QUALIS | Menicon Co., Ltd. New Business Division | 2014-06-18 | 236 | 0 |
| K140072 | CRYOTOP(R) SC | Kitazato Biopharma Co., Ltd. | 2014-04-03 | 80 | 0 |
| K131145 | PROINSERT | Nidacon International AB | 2014-02-20 | 303 | 0 |
| K122982 | CRYOLOCK | Biotech, Inc. | 2014-01-09 | 470 | 0 |
| K123641 | CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTUR | Hertart | 2013-07-03 | 219 | 0 |
| K112644 | SEAFORIA SPERM SEPARATION ASSISTANCE SYSTEM | Lotus Bio, Ltd. | 2012-12-19 | 464 | 0 |
| K112695 | CRYOTOP | Kitazato Biopharma Co;Ltd | 2012-12-12 | 454 | 0 |
| K112413 | RI MSC (MIGRATION SEDIMENTATION CHAMBER) | Research Instruments , Ltd. | 2012-07-13 | 326 | 0 |
| K103028 | EEVATM PETRI DISH | Auxogyn, Inc. | 2011-08-11 | 302 | 0 |
| K100596 | CRYOPETTE | Mid-Atlantic Diagnostics, Inc. | 2010-12-06 | 279 | 1 |
| K092398 | HSV STRAW | Cryo Bio System | 2010-10-06 | 426 | 0 |
| K090832 | RAPID-I | Vitrolife Sweden AB | 2009-12-23 | 272 | 0 |
| K090429 | NUNC IVF CENTERWELL AND ICSI DISHES | Thermo Fisher Scientific (Nalge Nunc Intl) | 2009-09-18 | 211 | 0 |
| K081896 | BIOGENICS BIOQUAD 4-WELL IVF CULTURE DISH | Biogenics, Inc. | 2008-08-20 | 48 | 0 |
| K080395 | SUNIVF DISHES | <Genx> Intl., Inc. | 2008-08-13 | 182 | 0 |
| K070047 | NUNC IVF DISHES AND NUNC IVF 4-WELL DISH | Nunc A/S | 2007-05-18 | 134 | 0 |
| K052457 | PICSI SPERM SELECTION DEVICE | Biocoat, Inc. | 2006-04-13 | 218 | 0 |
| K040717 | NUNC IVF MULTIDISH 4 WELLS NUNCLON | Nunc A/S | 2004-08-12 | 146 | 0 |
| K000915 | PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MO | Humagen Fertility Diagnostics, Inc. | 2000-05-12 | 51 | 2 |
| K994361 | ESP FOUR WELL TISSUE CULTURE PLATE, ESP SIX WELL TISSUE CULT | Genesis Industries, Inc. | 2000-02-18 | 53 | 0 |
| K993881 | GENX CULTURE DISH | <Genx> Intl., Inc. | 2000-02-14 | 90 | 0 |
| K990941 | NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MO | Humagen Fertility Diagnostics, Inc. | 1999-07-14 | 114 | 0 |
| K991251 | FALCON IVF ONE WELL DISH | Becton Dickinson Labware | 1999-05-05 | 22 | 0 |
| K991249 | FALCON IVF FOUR WELL PLATE | Becton Dickinson Labware | 1999-05-05 | 22 | 0 |
| K991253 | FALCON IVF ROUND DISH | Becton Dickinson Labware | 1999-05-05 | 22 | 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