510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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MQKClass II

Labware, Assisted Reproduction

21 CFR 884.6160 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

MQK is the FDA product code for Labware, Assisted Reproduction, a class II device type, regulated under 21 CFR 884.6160. As of , FDA records hold 50 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
MQK
Device name
Labware, Assisted Reproduction
Regulation
21 CFR 884.6160
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
Yes
Ingested clearances
50
Ingested recalls
4

Clearances, product code MQK

By decision year
50 clearances under product code MQK with a decision year between 1999 and 2025, 2014 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code MQK by decision year
YearClearances
19994
20003
20041
20061
20071
20082
20092
20102
20111
20123
20131
20146
20152
20162
20172
20184
20191
20202
20211
20222
20244
20253

Applicants with the most clearances

Product code MQK
Applicants holding the most 510(k) clearances under product code MQK
ApplicantClearances
CooperSurgical, Inc.5
Becton Dickinson Labware3
Hertart3
Kitazato Biopharma Co., Ltd.3
Vitrolife Sweden AB3
<Genx> Intl., Inc.2
Auxogyn, Inc.2
Nunc A/S2
Reprobitech Corp.2
Vitrolife Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 51 companies shown, in name order