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

JPI — Predicate Candidate Screening

15 FDA 510(k) clearances under this product code; the 50 most recent screened below.

47 daysmedian FDA review time

266 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K183680	i-STAT CHEM8+ cartridge with the i-STAT 1 System	Abbott Point of Care, Inc.	2020-02-28	427
K163342	i-STAT Hematocrit test with i-STAT Alinity System	Abbott Laboratories	2017-08-22	266
K950942	CRIT-LINE HEMATOCRIT ALERT	In-Line Diagnostics Corp.	1995-03-14	27
K924167	CRIT-LINE	Noninvasive Medical Technology Corp.	1993-05-07	261
K903698	STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBES	Statspin Technologies	1990-09-17	33
K902028	STATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READER	Norfolk Scientific, Inc.	1990-06-20	47
K870511	CHART-TYPE MICRO HEMATOCRIT TUBE READER	Norfolk Scientific, Inc.	1987-03-16	39
K852482	MICROSPIN MINICENTRIFUGE ITEM NO. 65204/94	Em Diagnostic Systems, Inc.	1985-07-15	34
K852516	CENTIFUGE, HEMATOCRIT & MICROSEDIMENTATION COMBINE	Whittaker General Medical	1985-07-15	32
K850391	PLASMA EXTRACTION SYSTEM	Hans J. Brouwers & Assoc.	1985-05-10	98
K840767	HAEMOFUGE A. BIOFUGE A. & B	Heraeus-Christ GmbH	1984-04-17	54
K831318	COMPUR* M1100 HEMATRCRIT SYSTEM	Worthington Diagnostic Systems	1983-06-08	47
K830578	MICROHEMATOCRIT READER	Fisher Scientific Co., LLC	1983-03-24	29
K823558	MICRO-HEMATOCRIT CENTRIFUGE 335/336	Fisher Scientific Co., LLC	1983-01-21	50
K822716	UNIVERSAL CENTRIFUGE	Biodynamics Corp.	1982-09-30	23

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