BUM Oil— 510(k) K261905

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
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Fort Lauderdale, FL, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code NUC

view all

Adverse events under product code NUC

product code NUC
Other
8
Total
8

Source: openFDA MAUDE database, through . 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.