Home / 510(k) Clearances / K013087

510(k) K013087

SINGLE DOSE DISPENSING PIN, MODEL 2201 by Alaris Medical Systems, Inc. — Product Code LHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 2001
Date Received
September 17, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, I.V. Fluid Transfer
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Alaris Medical Systems, Inc.

  • K043299 — MEDLEY PCA MODULE, MODEL 8120 (December 10, 2004)
  • K041241 — MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600 (July 6, 2004)
  • K031741 — MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300 (February 9, 2004)
  • K032233 — MEDLEY PCA MODULE, MODEL 8120 (September 9, 2003)
  • K032147 — SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 7 (July 25, 2003)
  • K030459 — MEDLEY SYSTEM WITH MEDICATION MANAGEMENT SYSTEM (MMS) (April 4, 2003)
  • K023264 — MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110 (December 19, 2002)
  • K022677 — MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE (September 11, 2002)
  • K022209 — ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS (August 6, 2002)
  • K012383 — GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PUMP (SE), MEDSYSTEM I (October 2, 2001)

Other clearances for product code LHI

  • K250345 — Medline Bag Decanter (October 24, 2025)
  • K251715 — FlowArt® Vial Access Device Vented (October 14, 2025)
  • K251676 — Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decan (September 16, 2025)
  • K243404 — HyHub™ and HyHub™ Duo Vial Access Devices (July 18, 2025)
  • K240761 — Arisure® Closed Male Luer with Spike Adapter (YM060) (March 21, 2025)
  • K243985 — Rio™ Drug Reconstitution Transfer Device (January 22, 2025)
  • K243486 — SmartSiteTM Vented Vial Access Device (December 6, 2024)
  • K241976 — nextaro® va, 15mm, 5µm (September 6, 2024)
  • K233287 — Vent Vial Adapter (July 26, 2024)
  • K232987 — FlowArt Valve for Vial Access (June 26, 2024)