510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K834528Substantially Equivalent

Model 2001 Intelligent Infusor

Quest Medical, Inc, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K834528 is the FDA 510(k) clearance record for MODEL 2001 INTELLIGENT INFUSOR, a class II device, cleared for Quest Medical, Inc. on under FDA product code LDR (Controller, Infusion, Intravascular, Electronic). FDA records list 39 510(k) clearances for Quest Medical, Inc., from to . As of , FDA records show no recalls naming K834528.

Clearance record

Decision date
Received
(62 days to decision)
Product code
LDR Controller, Infusion, Intravascular, Electronic
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Quest Medical, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code LDR

Trailing 12 months

FDA records hold no clearances under product code LDR in the trailing twelve months.

FDA records show no clearances under product code LDR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LDR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260