Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)— 510(k) K260134

Substantially Equivalent

Shenzhen Root Innovation Technology Co., Ltd.

FDA 510(k) clearance K260134 for Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021), Substantially Equivalent on 2026-05-15. Applicant: Shenzhen Root Innovation Technology Co., Ltd..

Clearance details

Applicant: Shenzhen Root Innovation Technology Co., Ltd.
Product code: Code BTA
Advisory panel: General, Plastic Surgery
Date received: 2026-01-16
Decision date: 2026-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code BTA

product code BTA

Death: 5
Total: 5

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.