510(k) K260134 ยท BTA Pump, Portable, Aspiration (Manual Or Powered)
Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)
| Applicant | Shenzhen Root Innovation Technology Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, May 15, 2026 |
| Received | Jan 16, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260134
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.