# K260134: Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Root Innovation Technology Co., Ltd.
- Decided: May 15, 2026 after 119 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: 9 generations back to K935218 (1994). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K244033: Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610), Shenzhen Desida Technology Co., Ltd. (2025) Summary page 5.
- K241852: Nasal Aspirator (NS 13), Avita Corporation (2024) Summary page 5.
- K981602: Devilbiss Model 6305D Heavy Duty AC Aspirator, Sunrise Medical Hhg, Inc. (1998) Summary page 5.

## Indications for use
The BNO06 series (BNO06, BNO06-A, BNO06-B, BNO06-C, BNO06-D, BNO2) is intended for intermittent removal of nasal secretions and mucus from children (age 2-12 years old). This device is used in a home environment. The BNO08 series (BNO08, BNO08-A, BNO08-B, BNO08-C, BNO08-D, BC-021) is intended for intermittent removal of nasal secretions and mucus from children (age 2-12 years old). This device is used in a 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/K260134
Methodology: https://510kreport.com/methodology