FDA product code LQK: Home Uterine Activity Monitor
LQK is the FDA product code for home uterine activity monitor. It is a Class II device, regulated under 21 CFR 884.2730 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 6 510(k) submissions under LQK, 2 in the last five years, from 4 different applicants. The average 510(k) review took 162 days (median 138); 286 days on average over the last three years. 2 PMA applications cite this product code. FDA has posted 1 recall for LQK devices.
Classification
| Field | Value |
|---|---|
| Device name | Home Uterine Activity Monitor |
| Device class | Class II |
| Regulation | 21 CFR 884.2730 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
510(k) clearances per year for LQK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 308 |
| 2021 | 1 | 144 |
| 2022 | 1 | 28 |
| 2026 | 1 | 286 |
Compare with all 510(k) review times · Search every LQK clearance
Top LQK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nuvo- Group , Ltd. | 3 | 2022-05-06 |
| Marani Health, Inc. | 1 | 2026-09-03 |
| Airstrip Technologies, Inc. | 1 | 2015-03-10 |
| Huntleigh Diagnostics , Ltd. | 1 | 2002-04-19 |
Most recent LQK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253673 | Marani Health, Inc. | Mcare System (MW-20) | 2026-09-03 | 286 |
| K221046 | Nuvo- Group , Ltd. | Invu by Nuvo | 2022-05-06 | 28 |
| K210025 | Nuvo- Group , Ltd. | INVU by Nuvo | 2021-05-28 | 144 |
| K191401 | Nuvo- Group , Ltd. | PregSense | 2020-03-27 | 308 |
| K143114 | Airstrip Technologies, Inc. | Sense4Baby System Model B+ (MSA) | 2015-03-10 | 131 |
Recalls for LQK devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-08-04.
Frequently asked questions
What is FDA product code LQK?
LQK is the FDA product code for home uterine activity monitor. It is a Class II device, regulated under 21 CFR 884.2730 and reviewed by the Obstetrics and Gynecology panel.
What device class is LQK?
Class II, regulation 21 CFR 884.2730. Typical premarket route: 510(k).
How long does a 510(k) take for product code LQK?
Across 6 cleared submissions the average was 162 days from receipt to decision (median 138).
Which companies have the most LQK clearances?
Nuvo- Group , Ltd. (3); Marani Health, Inc. (1); Airstrip Technologies, Inc. (1); Huntleigh Diagnostics , Ltd. (1).
Have LQK devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2016-08-04.
Next steps
- Run an FDA pathway report with predicate devices for product code LQK
- Run a recall and safety report across every LQK manufacturer
- Watch product code LQK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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