Home / 510(k) Clearances / K130001

510(k) K130001

CARE SU01A SUCTION ASPIRATOR by Foshan Care Medical Technology Co., Ltd. — Product Code JCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2013
Date Received
January 2, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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 Foshan Care Medical Technology Co., Ltd.

  • K240840 — Oxygen Concentrator (ZY-10AB/115) (December 6, 2024)
  • K101552 — FOSHAN CARE MEDICAL NEBULIZER MODEL KYWH2001 (March 14, 2011)
  • K102245 — CARE ZY5BA OXYGEN CONCENTRATOR (November 9, 2010)

Other clearances for product code JCX

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