FDA product code MQL: Media, Reproductive
MQL is the FDA product code for media, reproductive. It is a Class II device, regulated under 21 CFR 884.6180 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 260 510(k) submissions under MQL, 32 in the last five years, from 50 different applicants. The average 510(k) review took 158 days (median 129); 189 days on average over the last three years. FDA has posted 15 recalls for MQL devices, 9 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Media, Reproductive |
| Device class | Class II |
| Regulation | 21 CFR 884.6180 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
510(k) clearances per year for MQL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 10 | 152 |
| 2018 | 4 | 126 |
| 2019 | 6 | 169 |
| 2020 | 8 | 275 |
| 2021 | 1 | 228 |
| 2022 | 3 | 282 |
| 2023 | 5 | 202 |
| 2024 | 12 | 188 |
| 2025 | 9 | 208 |
| 2026 | 3 | 170 |
Compare with all 510(k) review times · Search every MQL clearance
Top MQL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Irvine Scientific Sales Co., Inc. | 36 | 2017-08-31 |
| Vitrolife Sweden AB | 28 | 2024-08-07 |
| Medicult A/S | 26 | 2008-12-18 |
| <Genx> Intl., Inc. | 15 | 2012-05-03 |
| Nidacon International AB | 11 | 2010-06-15 |
45 more applicants have MQL clearances. See the full list in Caduvo.
Most recent MQL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254261 | CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD. | Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK) | 2026-08-28 | 241 |
| K260248 | Kitazato Corporation | Ultra-Fast Warm | 2026-04-28 | 91 |
| K252672 | Casebioscience, Inc. | CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5) | 2026-02-20 | 179 |
| K250445 | Fujifilm Irvine Scientific | Fast Warm - NX | 2025-09-12 | 210 |
| 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]) | 2025-08-27 | 90 |
Recalls for MQL devices
15 product recalls in 11 recall events; 9 initiated in the last five years and 11 still open. Most recent: 2024-02-16.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2021 | 2 |
| 2022 | 2 |
| 2023 | 4 |
| 2024 | 3 |
Frequently asked questions
What is FDA product code MQL?
MQL is the FDA product code for media, reproductive. It is a Class II device, regulated under 21 CFR 884.6180 and reviewed by the Obstetrics and Gynecology panel.
What device class is MQL?
Class II, regulation 21 CFR 884.6180. Typical premarket route: 510(k).
How long does a 510(k) take for product code MQL?
Across 260 cleared submissions the average was 158 days from receipt to decision (median 129).
Which companies have the most MQL clearances?
Irvine Scientific Sales Co., Inc. (36); Vitrolife Sweden AB (28); Medicult A/S (26); <Genx> Intl., Inc. (15); Nidacon International AB (11).
Have MQL devices been recalled?
Yes: 15 product recalls across 11 recall events; the most recent began 2024-02-16.
Next steps
- Run an FDA pathway report with predicate devices for product code MQL
- Run a recall and safety report across every MQL manufacturer
- Watch product code MQL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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