Product code MQL: 510(k) clearances and predicates
Product code MQL covers Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK). FDA lists 260 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
260 clearances on file under product code MQL. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 3 |
| 2023 | 5 |
| 2024 | 12 |
| 2025 | 9 |
| 2026 so far | 3 |
Recent clearances
Newest MQL clearances in the FDA index, with applicant and decision date:
- K254261, Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK), applicant CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD., decided 2026-08-28. FDA record
- K260248, Ultra-Fast Warm, applicant Kitazato Corporation, decided 2026-04-28. FDA record
- K252672, CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5), applicant Casebioscience, Inc., decided 2026-02-20. FDA record
- K250445, Fast Warm - NX, applicant Fujifilm Irvine Scientific, decided 2025-09-12. FDA record
- K251637, Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA]), applicant Donnevie Medical Technology (Shanghai) Co. , Ltd., decided 2025-08-27. FDA record
- K251305, Ultra-Fast Vitri; Ultra-Fast Warm, applicant Kitazato Corporation, decided 2025-08-26. FDA record
- K242640, FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin, applicant Fertipro NV, decided 2025-05-30. FDA record
- K242089, Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202), applicant Jiangsu Ruifuda Medical Device Co., Ltd., decided 2025-04-10. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Ultra-Fast Warm, CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5). Watch new MQL clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code MQL?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent MQL clearances include Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK).
How many 510(k) clearances use product code MQL?
260 at the time this page was generated, from openFDA records.
How do I find a predicate device under MQL?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new MQL clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
Get this for MQL, every week.
$49/month. Unlimited codes, one seat covers every client. Cancel anytime.
7-day free trial on the monthly plan. Card required, pay nothing for 7 days. 7-day money-back guarantee. Secure checkout via Stripe.
Not ready? Get one free MQL brief
Tell us where to send it. No card required.
You are on the list.
We will email your free MQL brief shortly. MQL is already in your watchlist draft. Want the ongoing watch instead of one brief? See the 7-day free trial.
Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.