Chrysalis Intelligence · Product Codes · MQL

MQL · Media, Reproductive

Obstetrics/Gynecology · 40 clearances · 17 unique sponsors

Device class
Class II
Regulation 884.6180
Total clearances
40
2020-04-23 → 2026-04-28
Last 12 months
3
Unique sponsors
17
Medical specialty
Obstetrics/Gynecology
Review panel
OB
Regulation number
884.6180
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Vitromed GmbH 6 0 2025-03-21
Gimbo Medical Technology Shenzhen Co., Ltd. 5 0 2025-01-08
Kitazato Corporation 5 1 2026-04-28
Donnevie Medical Technology (Shanghai) Co. , Ltd. 4 0 2025-08-27
Artsmedia Denmark Aps 3 0 2024-12-18
Vitrolife Sweden AB 2 0 2024-08-07
Shenzhen Vitavitro Biotech Co., Ltd. 2 0 2022-02-01
Hamilton Thorne Incorporated 2 0 2020-11-19
Fujifilm Irvine Scientific 2 1 2025-09-12
Casebioscience, Inc. 2 1 2026-02-20
Fertipro NV 1 0 2025-05-30
Shandong Wego Ruisheng Medical Device Co., Ltd. 1 0 2024-07-01
Jiangsu Ruifuda Medical Device Co., Ltd. 1 0 2025-04-10
Zhejiang Horizon Medical Technology Co., Ltd. 1 0 2023-05-11
Ecmpc, LLC 1 0 2024-08-27
Vitromed Langenfeld 1 0 2022-09-14
Origio A/S, A Coopersurgical Company 1 0 2020-07-17
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
A4291 HCPCS Medium Media, reproductive, per item
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-04-28 K260248 Kitazato Corporation Ultra-Fast Warm
2026-02-20 K252672 Casebioscience, Inc. CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)
2025-09-12 K250445 Fujifilm Irvine Scientific Fast Warm - NX
2025-08-27 K251637 Donnevie Medical Technology (Shanghai) Co. , Ltd. Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])
2025-08-26 K251305 Kitazato Corporation Ultra-Fast Vitri; Ultra-Fast Warm
2025-05-30 K242640 Fertipro NV FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin
2025-04-10 K242561 Donnevie Medical Technology (Shanghai) Co. , Ltd. Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)
2025-04-10 K242089 Jiangsu Ruifuda Medical Device Co., Ltd. Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)
2025-03-21 K242107 Casebioscience, Inc. CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF)
2025-03-21 K241833 Vitromed GmbH V-GRAD
2025-01-08 K242043 Gimbo Medical Technology Shenzhen Co., Ltd. Sperm Freezing Medium
2024-12-18 K241132 Artsmedia Denmark Aps ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100)
2024-12-18 K241095 Artsmedia Denmark Aps ARTSMedia Semen Wash Medium
2024-11-22 K242968 Gimbo Medical Technology Shenzhen Co., Ltd. Giftlife® Single-Step Medium Plus
2024-09-13 K240176 Vitromed GmbH V-VITFREEZE and V-VITWARM
2024-08-27 K233846 Ecmpc, LLC Vitrification Solution Set and Warming Solution Set
2024-08-07 K240605 Vitrolife Sweden AB Ultra RapidWarm™ Blast
2024-07-01 K233477 Shandong Wego Ruisheng Medical Device Co., Ltd. Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML)
2024-06-13 K240149 Gimbo Medical Technology Shenzhen Co., Ltd. Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst Medium; Giftlife™ Single Step Medium
2024-05-10 K234023 Gimbo Medical Technology Shenzhen Co., Ltd. Oocyte Flushing & Retrieval Medium; Gamete Buffer
2024-04-24 K233764 Fujifilm Irvine Scientific SSS-NX (Serum Substitute Supplement-NX)
2024-03-20 K232125 Vitromed GmbH V-PVP
2024-01-30 K232942 Gimbo Medical Technology Shenzhen Co., Ltd. G-Vitri™ Vitrification Freeze Media; G-Vitri™ Vitrification Thawing Media
2023-08-04 K231370 Donnevie Medical Technology (Shanghai) Co. , Ltd. Dewin Blastocyst Medium (with HSA and without HSA)
2023-05-26 K222606 Vitromed GmbH V-HYADASE