510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K803078Substantially Equivalent

Simplicity Infusion Pump Model 2100A

Critikon Company, LLC, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K803078 is the FDA 510(k) clearance record for SIMPLICITY INFUSION PUMP MODEL 2100A, a class II device, cleared for Critikon Company, LLC on under FDA product code FRN (Pump, Infusion). FDA records list 51 510(k) clearances for Critikon Company, LLC, from to . As of , FDA records show no recalls naming K803078.

Clearance record

Decision date
Received
(54 days to decision)
Product code
FRN Pump, Infusion
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Critikon Company, LLC 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FRN

Trailing 12 months
2 clearances under product code FRN in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FRN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260