510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K901141Substantially Equivalent

Paramax 520, Paramax 720 and Paramax 720Zx

Baxter Healthcare Corporation, Santa Ana CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901141 is the FDA 510(k) clearance record for PARAMAX 520, PARAMAX 720 AND PARAMAX 720ZX, a class I device, cleared for Baxter Healthcare Corp on under FDA product code JJC (Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K901141.

Clearance record

Decision date
Received
(27 days to decision)
Product code
JJC Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use
Regulation
21 CFR 862.2150
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Baxter Healthcare Corp P.O. Box 25101, Santa Ana CA
Third party review
No

Clearances, product code JJC

Trailing 12 months

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

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