Home / 510(k) Clearances / K260134

510(k) 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) by Shenzhen Root Innovation Technology Co., Ltd. — Product Code BTA

K260134 is an FDA 510(k) premarket notification submitted by Shenzhen Root Innovation Technology Co., Ltd. for the device "Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)". The FDA issued a decision of Substantially Equivalent on May 15, 2026. The device falls under product code BTA (Pump, Portable, Aspiration (Manual Or Powered)), a Class II device regulated under 21 CFR 878.4780. Shenzhen Root Innovation Technology Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2026
Date Received
January 16, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Portable, Aspiration (Manual Or Powered)
Device Class
Class II
Regulation Number
878.4780
Review Panel
SU
Submission Type

Other clearances by Shenzhen Root Innovation Technology Co., Ltd.

  • K254254 — Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D) (June 18, 2026)
  • K260538 — Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D ) (June 17, 2026)
  • K253629 — Momcozy Nasal Aspirator (BN007) (May 26, 2026)
  • K253914 — Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, (April 29, 2026)
  • K254258 — Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y- (April 8, 2026)
  • K253946 — Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D, S9 (April 7, 2026)
  • K253934 — Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, (March 9, 2026)
  • K253283 — Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP4 (October 29, 2025)
  • K251394 — Momcozy Wearable Breast Pump (BP223) (September 8, 2025)
  • K241680 — Momcozy Wearable Breast Pump (BP311) (December 20, 2024)

Other clearances for product code BTA

  • K253629 — Momcozy Nasal Aspirator (BN007) (May 26, 2026)
  • K260892 — Suction Pump (SU-90) (May 14, 2026)
  • K260473 — Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B) (May 12, 2026)
  • K253107 — Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90) (April 14, 2026)
  • K260147 — Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036) (March 13, 2026)
  • K251450 — Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator (June 6, 2025)
  • K244033 — Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA61 (May 16, 2025)
  • K251101 — AIRO Suction Unit (AIRO-01) (April 26, 2025)
  • K250697 — Electric Nasal Aspirator (BC026, BC025, BC023) (April 23, 2025)
  • K241799 — ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose sys (March 7, 2025)

FDA data resources