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510(k) K172481

IntelliCart System by Dornoch Medical Systems — Product Code JCX

K172481 is an FDA 510(k) premarket notification submitted by Dornoch Medical Systems for the device "IntelliCart System". The FDA issued a decision of Substantially Equivalent on September 14, 2017. The device falls under product code JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered), a Class II device regulated under 21 CFR 878.4780. Dornoch Medical Systems has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2017
Date Received
August 16, 2017
Clearance Type
Special
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 Dornoch Medical Systems

  • K190789 — IntelliCartTM System (April 24, 2019)
  • K162421 — IntelliCartTM System (December 21, 2016)
  • K133786 — DORNOCH DUO SUCTION CART WITH: DL2800 LID, CL500 LID, DORNOCH QUAD SUCTION CART (March 21, 2014)
  • K123188 — DORNOCH DUO SUCTION CART WITH DL2800 LID MODEL UL-DU2800, DORNOCH DUO SUCTION CA (March 4, 2013)
  • K081047 — TRANSPOSAL ULTRA SYSTEMS (April 29, 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