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

KRX — Predicate Candidate Screening

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

96 daysmedian FDA review time

237 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days
K160585	XN CAL	Streck	2016-12-22	296
K141962	XN CAL	Streck	2014-12-05	140
K141955	XN CAL PF	Streck	2014-12-05	140
K120747	XN CAL PF	Streck	2012-10-22	224
K120745	XN CAL	Streck	2012-10-19	221
K111204	CELL-DYN 22 PLUS CALIBRATOR	Streck	2011-12-22	237
K083200	X-CAL	Streck	2009-02-03	96
K020469	CAL-CHEX CD PLUS	Streck Laboratories, Inc.	2002-04-04	51
K003991	CD-CAL PLUS CALIBRATOR	R&D Systems, Inc.	2001-01-16	21
K993375	CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER	Clinical Diagnostic Solutions, Inc.	1999-12-20	74
K955925	CBC-CAL PLUS HEMATOLOGY CALIBRATOR	R&D Systems, Inc.	1996-02-29	69
K912357	3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE	R&D Systems, Inc.	1991-07-09	42
K862858	CBC-CAL (TM) PLUS/MULTIPLE	R&D Systems, Inc.	1986-08-21	23
K831140	DADE HEMATOLOGY CALIBRATOR	American Dade	1983-06-08	62
K811741	CELL-CHEX RBC	Streck Laboratories, Inc.	1981-09-24	97
K811063	LASER-CAL	Diagnostic Technology, Inc.	1981-07-01	75

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