Livi Device— 510(k) K252005

Name: FDA 510(k) clearance K252005
Creator: U.S. Food and Drug Administration
Published: 2026-03-20

Substantially Equivalent

Liviwell, Inc.

FDA 510(k) clearance K252005 for Livi Device, Substantially Equivalent on 2026-03-20. Applicant: Liviwell, Inc.. Device class: 2.

Summary

Liviwell's Livi Device is filed under HEB, unscented menstrual tampons. The record doesn't describe the device beyond its name and that code name.

Class II, 21 CFR 884.5470. Obstetrics/Gynecology is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Liviwell filed from Mountain Lakes, New Jersey. Review took 266 calendar days (June 27, 2025 to March 20, 2026).

Clearance details

Applicant: Liviwell, Inc.
Product code: Product code HEB
Device class: Class 2
Regulation: 21 CFR 884.5470
Advisory panel: Obstetrics/Gynecology
Date received: 2025-06-27
Decision date: 2026-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain Lakes, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HEB

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K253719 — Unscented Menstrual Long Applicator Tampon +2 more2025-12-17
K252939 — COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS2025-10-09
K252613 — Unscented menstrual three-piece applicator tampon2025-09-19
K251033 — Unscented menstrual long applicator tampon +3 more2025-08-13
K242105 — SABA Tampons2025-04-01

Adverse events under product code HEB

product code HEB

Injury: 329
Malfunction: 5,647
Total: 5,976

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.