Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

I-Stat Corp. — Predicate Candidate Screening

14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

74 daysmedian FDA review time

192 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K012478	MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER	I-Stat Corp.	2001-08-20	18	0
K011478	I-STAT SYSTEM	I-Stat Corp.	2001-07-02	49	0
K001387	I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300	I-Stat Corp.	2000-10-05	156	13
K001154	I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER	I-Stat Corp.	2000-04-18	8	4
K992571	I-STAT SYSTEM	I-Stat Corp.	2000-02-10	192	4
K982071	I-STAT LACTATE TEST	I-Stat Corp.	1998-06-29	17	1
K973292	I-STAT SYSTEM	I-Stat Corp.	1997-10-20	48	2
K940918	I-STAT 200 PORTABLE CLINICAL ANALYZER	I-Stat Corp.	1994-05-10	74	16
K936081	I-STAT TESTS FOR ACID-BASE PARAMETERS	I-Stat Corp.	1994-02-24	65	1
K934642	I-STAT IONIZED CALCIUM TEST	I-Stat Corp.	1993-12-17	87	1
K934641	I-STAT CONTROL LEVELS 1,2,3	I-Stat Corp.	1993-12-09	79	0
K921477	I-STAT(TM) LEVELS 1,2,3 CONTROLS	I-Stat Corp.	1992-11-02	217	0
K912387	I-STAT MODEL 100 PORT CLIN ANALYZER & TEST PACK	I-Stat Corp.	1991-07-01	61	9
K894914	MODEL 100 PORTABLE CLINICAL ANALYZER AND TEST PACK	I-Stat Corp.	1989-10-16	75	6

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda