# K253629: Momcozy Nasal Aspirator (BN007)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Root Innovation Technology Co., Ltd.
- Decided: May 26, 2026 after 188 days
- Product code: BTA (Pump, Portable, Aspiration (Manual Or Powered))
- Device class: 2
- Regulation: 21 CFR 878.4780
- 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 K935218 (1994). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243138: Geon (S2) Nasal Aspirator, Geon Corporation (2025) Summary page 5.
- K241852: Nasal Aspirator (NS 13), Avita Corporation (2024) Summary page 5.

## Indications for use
The device is designed for using suction to remove nasal secretion and mucus in children (age 2~12 years old) at home environment. The additional spray function helps moisturize and soften nasal secretions in children (over 3 years old), making them easier to aspirate.

Source page: https://510kreport.com/device/K253629
Methodology: https://510kreport.com/methodology