Product code MQK— Obstetrics/Gynecology
VitriGuard
- Classification name
- Labware, Assisted Reproduction
- Device class
- Class 2
- Regulation
- 21 CFR 884.6160
- Advisory panel
- Obstetrics/Gynecology
- Total cleared
- 50
- First cleared
- Most recent
Market context for product code MQK
FDA has cleared devices under product code MQK between 1999 and 2025, filed by 35 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2025
- 2024
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
- 2011
- 2010
Top applicants under product code MQK
Recent clearances under product code MQK
- K241626 — SperSort Sperm Sorting Chip (IPG02)
- K241454 — Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)
- K241348 — SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)
- K241341 — cryo-GO Vitrification Device
- K240002 — G-Vitri Vitrification Straw
- K232980 — SpermAlign Sperm Separation Device
- K233177 — Nest VT Vitrification Device
- K221810 — LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device
- K213869 — EmbryoSlide+ ic8 dish
- K203626 — SureStrip Vitrification Straw, SureLock Vitrification Straw
- K201213 — Pasteur Pipette 3mL, Pasteur Pipette 1mL
- K200815 — VitriGuard
- K181461 — Rapid-i Kit
- K181469 — Cryotop®US-flash and Cryotop®US-scoop
- K180740 — VitriGuard
- K173075 — ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)
- K172751 — iVitri Straw
- K162640 — iVitri EZ
- K162833 — VitriGuard
- K162051 — Cryotec
- K153027 — Cryotop US
- K150961 — EmbryoSlide Culture Dish
- K150756 — Micro well group culture dish, 9-well; Micro well group culture dish, 16-well
- K140207 — RAPID-I KIT
- K141663 — EEVA DISH (WITH 12 MICROWELLS)
- K133295 — QUALIS
- K140072 — CRYOTOP(R) SC
- K131145 — PROINSERT
- K122982 — CRYOLOCK
- K123641 — CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH
- K112644 — SEAFORIA SPERM SEPARATION ASSISTANCE SYSTEM
- K112695 — CRYOTOP
- K112413 — RI MSC (MIGRATION SEDIMENTATION CHAMBER)
- K103028 — EEVATM PETRI DISH
- K100596 — CRYOPETTE
- K092398 — HSV STRAW
- K090832 — RAPID-I
- K090429 — NUNC IVF CENTERWELL AND ICSI DISHES
- K081896 — BIOGENICS BIOQUAD 4-WELL IVF CULTURE DISH
- K080395 — SUNIVF DISHES
- K070047 — NUNC IVF DISHES AND NUNC IVF 4-WELL DISH
- K052457 — PICSI SPERM SELECTION DEVICE
- K040717 — NUNC IVF MULTIDISH 4 WELLS NUNCLON
- K000915 — PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75
- K994361 — ESP FOUR WELL TISSUE CULTURE PLATE, ESP SIX WELL TISSUE CULTURE PLATE, ESP MICRO SIX WELL TISSUE CULTURE PLATE, ESP WELL
- K993881 — GENX CULTURE DISH
- K990941 — NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452L
- K991249 — FALCON IVF FOUR WELL PLATE
- K991251 — FALCON IVF ONE WELL DISH
- K991253 — FALCON IVF ROUND DISH
Data sourced from openFDA. This site is unofficial and independent of the FDA.