BUM Oil— 510(k) K261905

Name: FDA 510(k) clearance K261905
Creator: U.S. Food and Drug Administration
Published: 2026-08-07

Substantially Equivalent

Bumlicious, LLC (DBA Bumlicious)

FDA 510(k) clearance K261905 for BUM Oil, Substantially Equivalent on 2026-08-07. Applicant: Bumlicious, LLC (DBA Bumlicious). Device class: 2.

Summary

Bumlicious's BUM Oil is filed under product code NUC, personal lubricants. The record gives no other product details.

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

Bumlicious filed from Fort Lauderdale, Florida. The decision came 60 calendar days after FDA received it (June 8 to August 7, 2026), and it was substantially equivalent.

Clearance details

Applicant: Bumlicious, LLC (DBA Bumlicious)
Product code: Product code NUC
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2026-06-08
Decision date: 2026-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Lauderdale, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NUC

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K260117 — Everslide2026-09-23
K253989 — HARU Orgasm by jack herer water based lubricant (WL-OJ) +2 more2026-09-03
K261177 — PINKSLIP Water-Based Personal Lubricant and Moisturizer2026-07-09
K261909 — Plum Vagiceuticals Vaginal Moisturizing Suppositories2026-07-06
K254011 — Flow Water-Based Personal Lubricant2026-06-22

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.