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

I-Stat Corporation — Predicate Candidate Screening

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

112 daysmedian FDA review time

319 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K053597	I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP)	I-Stat Corporation	2006-07-21	210	2
K053110	Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abb	I-Stat Corporation	2006-01-13	70	3
K051433	I-STAT CREATINE KINASE MB (CK-MB)	I-Stat Corporation	2005-12-15	197	3
K031873	I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3; CARDIAC MA	I-Stat Corporation	2003-10-07	112	2
K023582	I-STAT KAOLIN ACT TEST	I-Stat Corporation	2003-09-08	319	2
K031739	I-STAT CARDIAC TROPONIN (CTNI) TEST	I-Stat Corporation	2003-09-02	90	4
K020355	I-STAT PROTHROMBIN TIME TEST	I-Stat Corporation	2002-05-14	99	5

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