Cleared Traditional

K261905 - BUM Oil

K261905 is an FDA 510(k) clearance for BUM Oil, manufactured by Bumlicious, LLC (DBA “Bumlicious”). The device is a Class 2 Obstetrics & Gynecology device with product code NUC cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K261905 · Bumlicious, LLC (DBA “Bumlicious”) · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
60d
Days
Class 2
Risk

K261905 is an FDA 510(k) clearance for the BUM Oil. Classified as Lubricant, Personal (product code NUC), Class II - Special Controls.

Submitted by Bumlicious, LLC (DBA “Bumlicious”) (Fort Lauderdale, US). The FDA issued a Cleared decision on August 7, 2026 after a review of 60 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bumlicious, LLC (DBA “Bumlicious”) devices

FDA 510(k) Submission Details - K261905

510(k) Number K261905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2026
Decision Date August 07, 2026
Days to Decision 60 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
100d faster than avg
Panel avg: 160d · This submission: 60d
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 212
Devices cleared under the same product code (NUC) and FDA review panel - the closest regulatory comparables to K261905.
PINKSLIP Water-Based Personal Lubricant and Moisturizer
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K260068 · Pjur Group Luxembourg S.A. · May 2026