Cleared Traditional

K254011 - Flow Water-Based Personal Lubricant

K254011 is an FDA 510(k) clearance for Flow Water-Based Personal Lubricant, manufactured by LBDO Group, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code NUC cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K254011 · LBDO Group, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2026
Decision
189d
Days
Class 2
Risk

K254011 is an FDA 510(k) clearance for the Flow Water-Based Personal Lubricant. Classified as Lubricant, Personal (product code NUC), Class II - Special Controls.

Submitted by LBDO Group, Inc. (Brooklyn, US). The FDA issued a Cleared decision on June 22, 2026 after a review of 189 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5300 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all LBDO Group, Inc. devices

FDA 510(k) Submission Details - K254011

510(k) Number K254011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2025
Decision Date June 22, 2026
Days to Decision 189 days
Submission Type Traditional
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
28d slower than avg
Panel avg: 161d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NUC Device Classification - Class 2, Special Controls

Product Code NUC Lubricant, Personal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5300
Definition This Device Is A Personal Lubricant, For Penile And/or Vaginal Application, Intended To Moisturize And Lubricate, To Enhance The Ease And Comfort Of Intimate Sexual Activity, And Supplement The Body's Natural Lubrication. This Product May Or May Not Be Compatible With Natural Rubber Latex, Polyisoprene, And/or Polyurethane Condoms.
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 Peers - NUC Lubricant, Personal

All 244
Devices cleared under the same product code (NUC) and FDA review panel - the closest regulatory comparables to K254011.
BUM Oil
K261905 · Bumlicious, LLC (DBA “Bumlicious”) · Aug 2026
PINKSLIP Water-Based Personal Lubricant and Moisturizer
K261177 · PINKSLIP, LLC · Jul 2026
Plum Vagiceuticals™ Vaginal Moisturizing Suppositories
K261909 · Pcca, Inc. · Jul 2026
PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)
K261292 · PR Personal Care Laboratories · Jun 2026
Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)
K252914 · Hathor Professional Skincare , Ltd. · Jun 2026
pjur NATURE Touch, 100 ml
K260068 · Pjur Group Luxembourg S.A. · May 2026