FDA product code · Obstetrics/Gynecology
MQLMedia, Reproductive
Product code MQL covers Media, Reproductive, a Class II device regulated under 21 CFR 884.6180. FDA has cleared 259 devices in this code, 5 of them in the last 12 months. Median review time across the 259 most recent decisions is 128 days. openFDA lists 15 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 884.6180
- Review panel
- Obstetrics/Gynecology
- Clearances
- 259
What is happening in MQL right now?
MQL (Media, Reproductive): nothing changed in the six FDA sources we watch.
Checked predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Nothing changed, so there is nothing here — which is the point. We only write when something did.
How many devices has FDA cleared in MQL?
FDA has cleared 259 devices under product code MQL since the 510(k) programme began in 1976, 5 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260248 | Ultra-Fast Warm | Kitazato Corporation | |
| K252672 | CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5) | Casebioscience, Inc. | |
| K250445 | Fast Warm - NX | Fujifilm Irvine Scientific | |
| 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]) | Donnevie Medical Technology (Shanghai) Co. , Ltd. | |
| K251305 | Ultra-Fast Vitri; Ultra-Fast Warm | Kitazato Corporation | |
| K242640 | FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin | Fertipro NV | |
| K242561 | Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit) | Donnevie Medical Technology (Shanghai) Co. , Ltd. | |
| K242089 | Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202) | Jiangsu Ruifuda Medical Device Co., Ltd. | |
| K242107 | CaseMONO Culture (CMON); CaseMONO w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF) | Casebioscience, Inc. | |
| K241833 | V-GRAD | Vitromed GmbH |
How long does FDA review take for MQL?
The median FDA review time for MQL is 128 days, measured across the 259 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in MQL?
openFDA lists 15 recall records against product code MQL. A recall record covers one firm's corrective action and may span many device lots.
Z-3296-2024Open, ClassifiedCooperSurgical, Inc.
Low concentration of sodium pyruvate in the wash could compromise gamete development
Z-3297-2024Open, ClassifiedCooperSurgical, Inc.
Low concentration of sodium pyruvate in the wash could compromise gamete development
Z-3298-2024Open, ClassifiedCooperSurgical, Inc.
Low concentration of sodium pyruvate in the wash could compromise gamete development
Z-1089-2024Open, ClassifiedCooperSurgical, Inc.
The firm has become aware of a sudden increase in complaints for three associated lots. Performance issues may lead to impaired embryo development prior to the blastocyst stage.
Z-0998-2024Open, ClassifiedFujifilm Irvine Scientific, Inc.
The lower layer component of a sperm separation Kit does not match the certificate of analysis. The kit should contain lower layer (Lot: 0000020686, Shelf Life: 31 December 2024) but incorrectly may contain lower layer (Lot number 9925811106, Shelf Life: 30 November 2023).
Showing the 5 most recently initiated of 15. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for MQL?
MAUDE holds 10 adverse-event reports naming product code MQL, 2 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in MQL unusual?
MQL does not yet have twelve months of adverse-event history in our data, so there is no expected range to compare against. That is a gap in what we hold, not a statement about the device.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history |
8 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike.
What are the predicate devices in MQL?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in MQL?
Across the 259 most recent decisions, these applicants filed most often in MQL.
| Applicant | Recent clearances |
|---|---|
| Irvine Scientific Sales Co., Inc. | 36 |
| Vitrolife Sweden AB | 28 |
| Medicult A/S | 26 |
| <Genx> Intl., Inc. | 15 |
| Nidacon International AB | 11 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in MQL files under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| <Genx> Intl., Inc. | 20 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch MQL
Get an email the morning anything changes in MQL — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.