510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K082182Substantially Equivalent

Ap 34 Multi-Therapy Infusion Pump

Q-Core, Ltd., Petach Tikva, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K082182 is the FDA 510(k) clearance record for AP 34 MULTI-THERAPY INFUSION PUMP, a class II device, cleared for Q-Core, Ltd. on under FDA product code FRN (Pump, Infusion). FDA records list one 510(k) clearance for Q-Core, Ltd. As of , FDA records show no recalls naming K082182.

Clearance record

Decision date
Received
(14 days to decision)
Product code
FRN Pump, Infusion
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Q-Core, Ltd. P.O. Box 3341, Petach Tikva, IL
510(k) summary
Summary PDF
Third party review
Yes

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