510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K802011Substantially Equivalent

Infussion Alarm System I.a.s. Cat.#1118

Pollak (Intl.).ltd, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K802011 is the FDA 510(k) clearance record for INFUSSION ALARM SYSTEM I.A.S. CAT.#1118, a class II device, cleared for Pollak (Intl.), Ltd. on under FDA product code FLN (Monitor, Electric For Gravity Flow Infusion Systems). FDA records list 31 510(k) clearances for Pollak (Intl.), Ltd., from to . As of , FDA records show no recalls naming K802011.

Clearance record

Decision date
Received
(72 days to decision)
Product code
FLN Monitor, Electric For Gravity Flow Infusion Systems
Regulation
21 CFR 880.2420
Device class
Class II
Review panel
General Hospital
Applicant
Pollak (Intl.), Ltd. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FLN

Trailing 12 months

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

FDA records show no clearances under product code FLN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FLN, 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