# K222175: Bloomi Delight Oil-Based Personal Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: The Bloomi Inc..
- Decided: Nov 15, 2022 after 117 days
- Product code: NUC (Lubricant, Personal)
- Device class: 2
- Regulation: 21 CFR 884.5300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K810310 (1981). 8 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171985: Astroglide O Oil Personal Lubricant & Massage Oil, Biofilm, Inc. (2017) Summary page 4.

## Most influential descendants
- K261905: BUM Oil (2026), 0 descendants of its own
- K232093: Woo More Play Coconut Love Oil (2023), 0 descendants of its own

## Indications for use
The Bloomi Delight Oil-Based Personal Lubricant is a personal lubricant for penile and/or vaginal application, intended to lubricate, moisturize, and enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.

Source page: https://510kreport.com/device/K222175
Methodology: https://510kreport.com/methodology