Flow Water-Based Personal Lubricant— 510(k) K254011

Name: FDA 510(k) clearance K254011
Creator: U.S. Food and Drug Administration
Published: 2026-06-22

Substantially Equivalent

LBDO Group, Inc.

FDA 510(k) clearance K254011 for Flow Water-Based Personal Lubricant, Substantially Equivalent on 2026-06-22. Applicant: LBDO Group, Inc.. Device class: 2.

Summary

LBDO Group's Flow Water-Based Personal Lubricant is filed under NUC, personal lubricants. The water-based description comes from the device name; the record doesn't list ingredients.

Class II, 21 CFR 884.5300. Obstetrics/Gynecology is both the classification panel and the review panel, and it came in as a Traditional 510(k).

LBDO filed from Brooklyn, New York. The decision came 189 calendar days after receipt (December 15, 2025 to June 22, 2026).

Clearance details

Applicant: LBDO Group, Inc.
Product code: Product code NUC
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2025-12-15
Decision date: 2026-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brooklyn, NY, US

Download summary PDF View on FDA.gov ↗

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K261909 — Plum Vagiceuticals Vaginal Moisturizing Suppositories2026-07-06

Adverse events under product code NUC

product code NUC

Other: 8
Total: 8

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.