MQLClass II
Media, Reproductive
21 CFR 884.6180 / Obstetrics/Gynecology
MQL is the FDA product code for Media, Reproductive, a class II device type, regulated under 21 CFR 884.6180. As of , FDA records hold 260 510(k) clearances under this code, the most recent dated , and 15 recalls.
Classification record
- Product code
- MQL
- Device name
- Media, Reproductive
- Regulation
- 21 CFR 884.6180
- Device class
- Class II
- Review panel
- Obstetrics/Gynecology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 260
- Ingested recalls
- 15
Clearances, product code MQL
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1987 | 1 |
| 1997 | 1 |
| 1998 | 1 |
| 1999 | 21 |
| 2000 | 47 |
| 2001 | 15 |
| 2002 | 29 |
| 2003 | 11 |
| 2004 | 9 |
| 2005 | 2 |
| 2006 | 9 |
| 2007 | 3 |
| 2008 | 12 |
| 2009 | 2 |
| 2010 | 6 |
| 2011 | 1 |
| 2012 | 5 |
| 2014 | 5 |
| 2015 | 7 |
| 2016 | 12 |
| 2017 | 10 |
| 2018 | 4 |
| 2019 | 6 |
| 2020 | 8 |
| 2021 | 1 |
| 2022 | 3 |
| 2023 | 5 |
| 2024 | 12 |
| 2025 | 9 |
| 2026 | 3 |
Applicants with the most clearances
Product code MQL| Applicant | Clearances |
|---|---|
| FUJIFILM Biosciences Inc. | 39 |
| Vitrolife Sweden AB | 28 |
| Medicult A/S | 26 |
| <Genx> Intl., Inc. | 20 |
| CooperSurgical, Inc. | 12 |
| Nidacon International AB | 11 |
| Invitrocare Inc | 10 |
| William A. Cook Australia Pty, Ltd. | 10 |
| Kitazato Corporation | 8 |
| Conception Technologies | 7 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
