Product code MQL— Obstetrics/Gynecology
EMBRYOGEN
- Classification name
- Media, Reproductive
- Device class
- Class 2
- Regulation
- 21 CFR 884.6180
- Advisory panel
- Obstetrics/Gynecology
- Total cleared
- 260
- First cleared
- Most recent
Market context for product code MQL
FDA has cleared devices under product code MQL between 1987 and 2026, filed by 49 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- 2026
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2012
- 2011
Top applicants under product code MQL
Recent clearances under product code MQL
1–100 of 260- K254261 — Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)
- K260248 — Ultra-Fast Warm
- K252672 — CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5)
- K250445 — Fast Warm - NX
- K251637 — Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA] +1 more
- K251305 — Ultra-Fast Vitri; Ultra-Fast Warm
- K242640 — FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin
- K242089 — Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)
- K242561 — Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)
- K241833 — V-GRAD
- K242107 — CaseMONO Culture (CMON); CaseMONO w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF)
- K242043 — Sperm Freezing Medium
- K241095 — ARTSMedia Semen Wash Medium
- K241132 — ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100)
- K242968 — Giftlife® Single-Step Medium Plus
- K240176 — V-VITFREEZE and V-VITWARM
- K233846 — Vitrification Solution Set and Warming Solution Set
- K240605 — Ultra RapidWarm Blast
- K233477 — Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML)
- K240149 — Giftlife Fertilization Medium; Giftlife Cleavage Medium; Giftlife Blastocyst Medium; Giftlife Single Step Medium
- K234023 — Oocyte Flushing & Retrieval Medium; Gamete Buffer
- K233764 — SSS-NX (Serum Substitute Supplement-NX)
- K232125 — V-PVP
- K232942 — G-Vitri Vitrification Freeze Media; G-Vitri Vitrification Thawing Media
- K231370 — Dewin Blastocyst Medium (with HSA and without HSA)
- K222606 — V-HYADASE
- K223265 — CryoX Vitrification Freeze Kit / Thaw Kit
- K220715 — ARTSMedia In Vitro Culture Medium (AM-IVC Medium)
- K223117 — V-SPERM WASH
- K213293 — V-HEPES PLUS
- K212426 — Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA])
- K212410 — VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium
- K202862 — Gx-IVF, Gx-TL, Gx-MOPS PLUS
- K193285 — V-ONESTEP
- K192503 — GM501 Wash with Phenol Red and Gentamicin
- K200249 — Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage Medium [without HSA/rHA, with HSA, with rHA], Blastocyst Medium [without HSA/rHA, with HSA, with rHA])
- K200408 — VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium
- K193522 — iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA
- K192845 — Sperm Freeze, Sperm Fridge
- K200680 — Synvitro Hyadase
- K192644 — GM501 SpermAir and GM501 SpermActive
- K190199 — SepaSperm Washing Solution, SepaSperm Solution
- K191552 — GM501 Mineral Oil
- K190383 — GM501 Wash
- K191063 — 1-Step Culture Medium
- K183486 — RapidVit Oocyte, RapidWarm Oocyte
- K190152 — Vit Kit- Freeze NX and Vit Kit- Warm NX
- K182002 — Cumulus Remover
- K180073 — Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set
- K173624 — ORIGIO® Handling without phenol red (Cat. No. 8310), ORIGIO® Handling with phenol red (Cat. No. 8311)
- K173731 — SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031)
- K171748 — Vitrification Kit and Thawing Kit
- K172197 — SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS
- K170498 — Gems Oocyte Retrieval Buffer ORB-20, ORB-50
- K171224 — Arctic Sperm Cryopreservation Medium
- K170681 — Continuous Single Culture -NX (CSCM-NX)
- K170602 — Continuous Single Culture-NX Complete (CSCM-NXC)
- K162409 — Gems Vitrification Set, Gems Warming Set
- K161261 — Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase
- K170560 — SAGE Vitrification Kit and SAGE Vitrification Warming Kit
- K170257 — Sydney IVF Culture Oil
- K160864 — Cryotop Vitrification Kit and Cryotop Thawing Kit
- K153478 — Sydney IVF Gamete Buffer
- K160863 — PBS(-), Phosphate Buffered Saline
- K153267 — ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash
- K152717 — Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit
- K152682 — Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit
- K160006 — Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos and PN zygotes Vitrification Thaw Kit
- K160814 — Sydney IVF Sperm Cryopreservation Buffer
- K160142 — MINERAL OIL
- K152932 — BlastGen
- K151367 — Sydney IVF Hyaluronidase
- K153290 — Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium
- K150950 — FreezeKit Cleave , ThawKit Cleave
- K152782 — SYDNEY IVF SPERM MEDIUM, SYDNEY IVF SPERM GRADIENT KIT, SYDNEY IVF SPERMIENT
- K152904 — SYDNEY IVF EMBRYO BIOPSY MEDIUM
- K152440 — Sydney IVF PVP
- K143724 — COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming Kit
- K142991 — LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, LifeGlobal Global Total w/HEPES W/HSA
- K143498 — LifeGlobal Global HP
- K133568 — G-TL
- K140317 — EMBRYOGEN
- K133912 — ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO SEQUENTIAL CLEAV, ORIGIO SEQUENTIAL CLEAV, ORIGIO
- K133387 — ORIGIO(R) SEQUENTIAL BLAST TM; ORIGIO(R) SEQUENTIAL BLAST TM WITH PHENOL RED
- K133707 — SAGE 1-STEP WITH HUMAN SERUM ALBUMIN, SAGE 1-STEP WITH SERUM PROTEIN SUPPLEMENTS
- K113786 — SPERMFREEZE SOLUTION
- K120136 — EMBRYOGEN
- K121572 — CONTINUOUS SINGLE CULTURE COMPLETE
- K121128 — MULTIPURPOSE HANDLING MEDIUM
- K112083 — LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES
- K092963 — GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3
- K101003 — RAPIDVIT BLAST, RAPIDWARM BLAST
- K100367 — MEDICULT VITRIFICATION COOLING/WARMING, MODEL REF: 1228, 1229
- K092107 — VITRIBLAST, THERMOBLAST, MODEL VB-010, TB-010
- K092667 — GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT
- K092578 — LIFEGLOBAL PROTEIN SUPPLEMENT
- K093273 — VIT KIT - FREEZE AND THAW
- K082363 — COOK SYDNEY IVF BLASTOCYST VITRIFICATION (K-SIBV-5000), WARMING (K-SIBW-5000) KITS
- K083509 — LIFEGLOBAL HUMAN SERUM ALBUMIN LG HSA
- K080172 — BLASTASSIST WITHOUT PHENOL RED, MODEL REF 1215, BLASTASSIST WITH PHENOL RED, MODEL REF 1216
Data sourced from openFDA. This site is unofficial and independent of the FDA.