Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MQL — Predicate Candidate Screening
259 FDA 510(k) clearances under this product code; the 50 most recent screened below.
128 daysmedian FDA review time
312 days90th percentile
259clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260248 | Ultra-Fast Warm | Kitazato Corporation | 2026-04-28 | 91 | 0 |
| K252672 | CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5 | Casebioscience, Inc. | 2026-02-20 | 179 | 0 |
| K250445 | Fast Warm - NX | Fujifilm Irvine Scientific | 2025-09-12 | 210 | 0 |
| K251637 | Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and | Donnevie Medical Technology (Shanghai) Co. , Ltd. | 2025-08-27 | 90 | 0 |
| K251305 | Ultra-Fast Vitri; Ultra-Fast Warm | Kitazato Corporation | 2025-08-26 | 120 | 0 |
| K242640 | FertiCult Flushing medium; FertiCult Flushing medium with ph | Fertipro NV | 2025-05-30 | 269 | 0 |
| K242089 | Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit ( | Jiangsu Ruifuda Medical Device Co., Ltd. | 2025-04-10 | 267 | 0 |
| K242561 | Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Tha | Donnevie Medical Technology (Shanghai) Co. , Ltd. | 2025-04-10 | 225 | 0 |
| K242107 | CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBios | Casebioscience, Inc. | 2025-03-21 | 246 | 0 |
| K241833 | V-GRAD | Vitromed GmbH | 2025-03-21 | 269 | 0 |
| K242043 | Sperm Freezing Medium | Gimbo Medical Technology Shenzhen Co., Ltd. | 2025-01-08 | 180 | 0 |
| K241132 | ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100) | Artsmedia Denmark Aps | 2024-12-18 | 238 | 0 |
| K241095 | ARTSMedia Semen Wash Medium | Artsmedia Denmark Aps | 2024-12-18 | 240 | 0 |
| K242968 | Giftlife® Single-Step Medium Plus | Gimbo Medical Technology Shenzhen Co., Ltd. | 2024-11-22 | 57 | 0 |
| K240176 | V-VITFREEZE and V-VITWARM | Vitromed GmbH | 2024-09-13 | 234 | 0 |
| K233846 | Vitrification Solution Set and Warming Solution Set | Ecmpc, LLC | 2024-08-27 | 267 | 0 |
| K240605 | Ultra RapidWarm™ Blast | Vitrolife Sweden AB | 2024-08-07 | 156 | 0 |
| K233477 | Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); V | Shandong Wego Ruisheng Medical Device Co., Ltd. | 2024-07-01 | 249 | 0 |
| K240149 | Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; G | Gimbo Medical Technology Shenzhen Co., Ltd. | 2024-06-13 | 146 | 0 |
| K234023 | Oocyte Flushing & Retrieval Medium; Gamete Buffer | Gimbo Medical Technology Shenzhen Co., Ltd. | 2024-05-10 | 142 | 0 |
| K233764 | SSS-NX (Serum Substitute Supplement-NX) | Fujifilm Irvine Scientific | 2024-04-24 | 152 | 0 |
| K232125 | V-PVP | Vitromed GmbH | 2024-03-20 | 247 | 0 |
| K232942 | G-Vitri™ Vitrification Freeze Media; G-Vitri™ Vitrification | Gimbo Medical Technology Shenzhen Co., Ltd. | 2024-01-30 | 132 | 0 |
| K231370 | Dewin Blastocyst Medium (with HSA and without HSA) | Donnevie Medical Technology (Shanghai) Co. , Ltd. | 2023-08-04 | 84 | 0 |
| K222606 | V-HYADASE | Vitromed GmbH | 2023-05-26 | 270 | 0 |
| K223265 | CryoX Vitrification Freeze Kit / Thaw Kit | Zhejiang Horizon Medical Technology Co., Ltd. | 2023-05-11 | 199 | 0 |
| K220715 | ARTSMedia In Vitro Culture Medium (AM-IVC Medium) | Artsmedia Denmark Aps | 2023-02-10 | 336 | 0 |
| K223117 | V-SPERM WASH | Vitromed GmbH | 2023-01-31 | 120 | 0 |
| K213293 | V-HEPES PLUS | Vitromed Langenfeld | 2022-09-14 | 348 | 0 |
| K212426 | Dewin Reproductive Media (Dewin Fertilization Medium [with H | Donnevie Medical Technology (Shanghai) Co. , Ltd. | 2022-06-16 | 316 | 0 |
| K212410 | VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Med | Shenzhen Vitavitro Biotech Co., Ltd. | 2022-02-01 | 182 | 0 |
| K202862 | Gx-IVF, Gx-TL, Gx-MOPS PLUS | Vitrolife Sweden AB | 2021-05-14 | 228 | 0 |
| K193285 | V-ONESTEP | Vitromed GmbH | 2020-11-20 | 359 | 0 |
| K192503 | GM501 Wash with Phenol Red and Gentamicin | Hamilton Thorne Incorporated | 2020-11-19 | 434 | 0 |
| K200249 | Sequential Culture Media (Fertilization Medium [without HSA/ | Kitazato Corporation | 2020-10-23 | 263 | 0 |
| K200408 | VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Me | Shenzhen Vitavitro Biotech Co., Ltd. | 2020-10-16 | 240 | 0 |
| K193522 | iMedium Single Step; iMedium Single Step with HSA; iMedium S | Kitazato Corporation | 2020-08-25 | 250 | 0 |
| K192845 | Sperm Freeze, Sperm Fridge | Kitazato Corporation | 2020-08-17 | 319 | 0 |
| K200680 | Synvitro Hyadase | Origio A/S, A Coopersurgical Company | 2020-07-17 | 123 | 0 |
| K192644 | GM501 SpermAir and GM501 SpermActive | Hamilton Thorne Incorporated | 2020-04-23 | 212 | 0 |
| K190199 | SepaSperm Washing Solution, SepaSperm Solution | Kitazato Corporation | 2019-09-26 | 234 | 0 |
| K191552 | GM501 Mineral Oil | Hamilton Thorne, Inc. | 2019-09-18 | 98 | 0 |
| K190383 | GM501 Wash | Hamilton Thorne, Inc. | 2019-09-05 | 198 | 0 |
| K191063 | 1-Step Culture Medium | Shenzhen Vitavitro Biotech Co., Ltd. | 2019-08-23 | 123 | 0 |
| K183486 | RapidVit™ Oocyte, RapidWarm™ Oocyte | Vitrolife Sweden AB | 2019-07-26 | 221 | 0 |
| K190152 | Vit Kit- Freeze NX and Vit Kit- Warm NX | Fujifilm Irvine Scientific, Inc. | 2019-06-21 | 142 | 0 |
| K182002 | Cumulus Remover | Kitazato Corporation | 2018-10-23 | 89 | 0 |
| K180073 | Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vita | Shenzhen Vitavitro Bio-Tech Co., Ltd. | 2018-08-29 | 232 | 0 |
| K173731 | SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrif | CooperSurgical, Inc. | 2018-03-02 | 86 | 0 |
| K173624 | ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO | Origio A/S | 2018-03-02 | 98 | 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