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

Home Uterine Activity Monitor

21 CFR 884.2730 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

LQK is the FDA product code for Home Uterine Activity Monitor, a class II device type, regulated under 21 CFR 884.2730. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
LQK
Device name
Home Uterine Activity Monitor
Regulation
21 CFR 884.2730
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
6
Ingested recalls
1

Clearances, product code LQK

By decision year
6 clearances under product code LQK with a decision year between 2002 and 2026, 2002 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LQK by decision year
YearClearances
20021
20151
20201
20211
20221
20261

Applicants with the most clearances

Product code LQK
Applicants holding the most 510(k) clearances under product code LQK
ApplicantClearances
Nuvo- Group, Ltd.3
AirStrip Technologies, Inc.1
Huntleigh Diagnostics, Ltd.1
Marani Health, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code