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510(k) K253107

Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90) by Shenzhen Dongjiang Technology Co., Ltd. — Product Code BTA

K253107 is an FDA 510(k) premarket notification submitted by Shenzhen Dongjiang Technology Co., Ltd. for the device "Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)". The FDA issued a decision of Substantially Equivalent on April 14, 2026. The device falls under product code BTA (Pump, Portable, Aspiration (Manual Or Powered)), a Class II device regulated under 21 CFR 878.4780.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2026
Date Received
September 24, 2025
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 for product code BTA

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  • K260134 — Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN (May 15, 2026)
  • K260892 — Suction Pump (SU-90) (May 14, 2026)
  • K260473 — Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B) (May 12, 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