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510(k) K180115

TWBM Pump by Taiwan Biomaterial Co., Ltd. — Product Code JCX

K180115 is an FDA 510(k) premarket notification submitted by Taiwan Biomaterial Co., Ltd. for the device "TWBM Pump". The FDA issued a decision of Substantially Equivalent on July 24, 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. Taiwan Biomaterial Co., Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2018
Date Received
January 16, 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 Taiwan Biomaterial Co., Ltd.

  • K190105 — ZOOM Aspiration Pump (February 21, 2019)

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)
  • K181398 — DV-300 Aspirator (July 23, 2018)

FDA data resources