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510(k) K181398

DV-300 Aspirator by Ding Hwa Co., Ltd. — Product Code JCX

K181398 is an FDA 510(k) premarket notification submitted by Ding Hwa Co., Ltd. for the device "DV-300 Aspirator". The FDA issued a decision of Substantially Equivalent on July 23, 2018. The device falls under product code JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered), a Class II device regulated under 21 CFR 878.4780. Ding Hwa Co., Ltd. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 2018
Date Received
May 29, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Ward Use, Portable, Ac-Powered
Device Class
Class II
Regulation Number
878.4780
Review Panel
SU
Submission Type

Other clearances by Ding Hwa Co., Ltd.

  • K140809 — CLIQ DV-300 ASPIRATOR (June 23, 2014)
  • K140031 — SUCTION PUMP (April 28, 2014)
  • K132308 — CLIQ DV-300 ASPIRATOR (December 30, 2013)
  • K080005 — SPARMAX ASPIRATOR, MODELS TC-2000V ND VC-701 (April 24, 2008)

Other clearances for product code JCX

  • K250964 — Protable Phlegm Suction Unit (JMA D01) (May 11, 2026)
  • K243638 — MV Flow Aspiration Pump (MVFLOWPMP01) (June 13, 2025)
  • K251111 — Cary (May 7, 2025)
  • K243418 — Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing (December 2, 2024)
  • K233428 — Easycess Aspiration Pump (November 3, 2023)
  • K222552 — 120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specime (December 9, 2022)
  • K182950 — Acare Suction Unit (August 23, 2019)
  • K190789 — IntelliCartTM System (April 24, 2019)
  • K190105 — ZOOM Aspiration Pump (February 21, 2019)
  • K180115 — TWBM Pump (July 24, 2018)

FDA data resources