510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001154Substantially Equivalent

I-Stat Model 200 Portable Clinical Analyzer

I-Stat Corp., East Windsor NJ / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K001154 is the FDA 510(k) clearance record for I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER, a class II device, cleared for I-Stat Corp. on under FDA product code JGS (Electrode, Ion Specific, Sodium). FDA records list 21 510(k) clearances for I-Stat Corp., from to . As of , FDA records show 4 recalls naming K001154.

Clearance record

Decision date
Received
(8 days to decision)
Product code
JGS Electrode, Ion Specific, Sodium
Regulation
21 CFR 862.1665
Device class
Class II
Review panel
Clinical Chemistry
Applicant
I-Stat Corp. 104 Windsor Center Dr., East Windsor NJ
510(k) summary
Summary
Third party review
No

Clearances, product code JGS

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