Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
MQG — Predicate Candidate Screening
46 FDA 510(k) clearances under this product code; the 50 most recent screened below.
126 daysmedian FDA review time
415 days90th percentile
46clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260194 | Vacuum Pump (Model: AD-VPUM-500) | Sheng Sheng Yi (Beijing) Technology Company Limited | 2026-04-28 | 96 | 0 |
| K242684 | Harioculture TL-16 Time-lapse Incubator | Hua Yue Medical Technology Co., Ltd. | 2025-05-22 | 258 | 0 |
| K232493 | Embryo Real-time Incubator (TLS301), Embryo Real-time Cultur | Wuhan Huchuang Union Technology Co., Ltd. | 2024-05-07 | 264 | 0 |
| K180188 | Geri Embryo Incubator with Geri Connect and Geri Assess Soft | Genea Biomedx Pty, Ltd. | 2018-06-07 | 135 | 0 |
| K173264 | EmbryoScope+ | Vitrolife A/S | 2018-05-11 | 212 | 0 |
| K180304 | Geri Embryo Incubator and Geri Dish | Genea Biomedx Pty, Ltd. | 2018-04-20 | 77 | 0 |
| K171736 | Geri Embryo Incubator and Geri Dish | Genea Biomedx Pty, Ltd. | 2017-11-15 | 156 | 0 |
| K160753 | COOK Vacuum Pump | William A. Cook Australia Pty. , Ltd. | 2017-06-13 | 452 | 0 |
| K160504 | RI Witness Embryology Heated Plate | Research Instruments Limited | 2016-07-18 | 145 | 0 |
| K151357 | MIRI TL | At Medical Uab | 2016-04-22 | 338 | 0 |
| K133712 | EMBRYOVIEWER SOFTWARE | Unisense Fertilitech A/S | 2014-08-08 | 246 | 0 |
| K132870 | Origio Gas Line Filter | Origio, Inc. | 2014-05-07 | 236 | 0 |
| K133742 | XQ-1 INCUBATOR | At Medical Uab | 2014-04-23 | 135 | 0 |
| K121566 | PLANER BT37 INCUBATOR | Planer Plc | 2012-11-29 | 184 | 2 |
| K113075 | EMBRYO VIEWER SOFTWARE | Unisense Fertilitech A/S | 2011-12-21 | 65 | 0 |
| K111715 | EMBRYOSCOPE | Unisense Fertilitech A/S | 2011-08-11 | 52 | 0 |
| K101988 | HEAL FORCE CO2 INCUBATOR | Shanghai Lishen Scientific Equipment Co., Ltd. | 2011-02-08 | 209 | 0 |
| K092183 | EMBRYOSCOPE AND EMBRYOSLIDE | Unisense Fertilitech A/S | 2011-01-11 | 539 | 0 |
| K050197 | MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045 | Minitube of America, Inc. | 2006-10-06 | 617 | 0 |
| K041952 | ZIVF-AIRE | Zander Medical Supplies, Inc. | 2005-09-08 | 415 | 0 |
| K032086 | KRYO ART CONTROLLED RATE FREEZER | Planer Plc | 2004-03-19 | 256 | 0 |
| K032526 | BINDER CO2 INCUBATOR SERIE CB | Binder GmbH | 2003-08-29 | 14 | 0 |
| K030525 | CUSTOM PRODUCTS IVF WORKSTATION TYPE WKST-24*36, WKST-24*48, | Mid-Atlantic Diagnostics, Inc. | 2003-08-27 | 189 | 0 |
| K023465 | KENDRO HERACELL 240 INCUBATOR | Kendro Laboratory Products, L.P. | 2003-03-10 | 146 | 0 |
| K011327 | DB1 EMBRYO FREEZE | Zander Medical Supplies, Inc. | 2002-08-15 | 471 | 0 |
| K020560 | WORKBENCH BY <GENX> | Genx Intl., Inc. | 2002-06-19 | 119 | 0 |
| K021042 | THERMO FORMA, CRYOMED, CONTROLLED RATE FREEZERS; MODELS # 74 | Thermo Forma, Inc. | 2002-05-15 | 44 | 0 |
| K014160 | PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIP | Cook Urological, Inc. | 2002-02-08 | 51 | 0 |
| K013703 | SANYO CO2 INCUBATORS, MODELS NOS. MCO-17AC, MCO-17AIC, MCO-2 | Sanyo North America Corp. | 2001-12-14 | 36 | 0 |
| K013401 | K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND | K-Systems, Kivex Biotec , Ltd. | 2001-12-14 | 60 | 0 |
| K002971 | MTG - MINITUB HEATED STAGE SYSTEMS | Zander Medical Supplies, Inc. | 2000-12-15 | 84 | 0 |
| K001600 | <GENX> CODA INCUBATOR CELLMATE | <Genx> Intl., Inc. | 2000-11-22 | 182 | 0 |
| K002961 | MINITUB MULTI-PURPOSE CASSETTES | Zander Medical Supplies, Inc. | 2000-11-21 | 60 | 0 |
| K003184 | RS BIOTECH GALAXY 'R' CO2 INCUBATOR | Zander Medical Supplies, Inc. | 2000-11-20 | 40 | 0 |
| K002595 | CBS STRAW | Cryo Bio System | 2000-11-17 | 88 | 0 |
| K002805 | KENDRO HERACELL CO2 INCUBATOR | Kendro Laboratory Products, L.P. | 2000-11-09 | 62 | 0 |
| K001486 | GENX CODA AIR PURIFICATION SYSTEM | <Genx> Intl., Inc. | 2000-09-15 | 126 | 0 |
| K001524 | FORMA SCIENTIFIC DIRECT HEAT INCUBATORS | Thermoquest Corp. | 2000-07-12 | 57 | 0 |
| K000394 | CRAFT DUO-VAC SUCTION UNIT AND CRAFT SUCTION UNIT | Rocket Medical Plc | 2000-02-29 | 22 | 0 |
| K992070 | COOK ULTRA QUIET VACUUM PUMP & REGULATOR | Cook Urological, Inc. | 1999-10-27 | 131 | 0 |
| K991216 | HOFFMAN IVF-1 | (Arms) Hoffman Surgical Equipment, Ivf Division | 1999-08-05 | 118 | 0 |
| K991408 | FORMA SCIENTIFIC UNIVERSAL WATER-JACKETED INCUBATOR | Thermoquest Corp. | 1999-07-19 | 88 | 0 |
| K991263 | THERMOPLATE | Tokai Hit Co., Ltd. | 1999-07-08 | 86 | 0 |
| K991229 | K-SYSTEMS WORK STATIONS, TYPE L-13W, L-13E, L-13ES, L-13ET, | Henning Knudsen Engineering A/S | 1999-06-29 | 78 | 0 |
| K983642 | COOK MINI-INCUBATOR | Cook Ob/Gyn | 1999-02-01 | 108 | 2 |
| K983609 | COOK TEST TUBE HEATER | Cook Ob/Gyn | 1998-12-16 | 63 | 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