Cleared Special

K221046 - Invu by Nuvo (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K221046 · Nuvo- Group , Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2022
Decision
28d
Days
Class 2
Risk

K221046 is an FDA 510(k) clearance for the Invu by Nuvo. Classified as Home Uterine Activity Monitor (product code LQK), Class II - Special Controls.

Submitted by Nuvo- Group , Ltd. (Tel Aviv, IL). The FDA issued a Cleared decision on May 6, 2022 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2730 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Nuvo- Group , Ltd. devices

Submission Details

510(k) Number K221046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2022
Decision Date May 06, 2022
Days to Decision 28 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
132d faster than avg
Panel avg: 160d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LQK Home Uterine Activity Monitor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2730
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Consultant

Hogan Lovells US LLP
Janice Hogan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.