Home / 510(k) Clearances / K874546

510(k) K874546

SIM MODULE by Critikon Company, LLC — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 1988
Date Received
November 3, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

Other clearances by Critikon Company, LLC

  • K002248 — DINAMAP PRO 1000 MONITOR, MODEL 1000 (September 21, 2000)
  • K000500 — DINAMAP ADVANCED NIBP MODULE (May 26, 2000)
  • K992638 — DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400 (February 24, 2000)
  • K982342 — DINAMAP MPS SELECT PORTABLE MONITOR (August 14, 1998)
  • K943709 — DINAMAP PLUS VITAL SIGNS MONOITOR (June 16, 1995)
  • K942700 — DINAMAP VITAL SIGNS MONITOR MODELS 9300 AND 9320/9340 (March 1, 1995)
  • K933404 — CRITIKON CENTRAL STATIN MONITOR (February 9, 1994)
  • K933050 — CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATH (December 14, 1993)
  • K915697 — CRITIKON VITAL SIGNS MODULE (July 1, 1993)
  • K921295 — INTRAVENOUS CATHETERS MODIFICATIONS (May 17, 1993)

Other clearances for product code FRN

  • K252015 — FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubin (January 28, 2026)
  • K251636 — Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) (July 28, 2025)
  • K251640 — SIGMA Spectrum Infusion Pump with Master Drug Library (July 28, 2025)
  • K242752 — MRidium 3870 MRI Infusion Pump System (3870) (May 28, 2025)
  • K243855 — BD Alaris Infusion System with Guardrails Suite MX (April 25, 2025)
  • K242115 — Plum Duo™ Precision IV Pump (April 2, 2025)
  • K242114 — Plum Solo™ Precision IV Pump (April 2, 2025)
  • K250357 — RemunityPRO™ Pump for Remodulin® (treprostinil) Injection (March 11, 2025)
  • K241736 — Remunity 2.0 Pump for Remodulin (treprostinil) Injection (January 16, 2025)
  • K242735 — Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Inf (December 23, 2024)