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

JKS · Predicate Candidate Screening

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

94 daysmedian FDA review time

221 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K951485	AVOXIMETER 4000	A-Vox Systems, Inc.	1995-11-06	221	2
K863825	CO-OXIMETER SOLUTIONS	D.R.G. Scientific Industries	1986-11-24	55	0
K862253	IL 482 CO-OXIMETER	Instrumentation Laboratory CO	1986-07-29	46	0
K853990	OSM3 HEMOXIMETER	Radiometer America, Inc.	1985-12-30	94	0
K833693	TEE ADAPTER 9890-FLUSH WINDING 282	Shaban Mfg. Co.	1983-12-30	73	0
K833211	BILE SALTS MIXTURE	Acumedia Manufacturers, Inc.	1983-10-27	38	0
K832066	CONTROL 282	Bio-Nustics, Inc.	1983-09-29	94	0
K780652	HEMOGLOBIN CHECK SOLUTIONS, S2100 OSM-2	The London Co.	1978-07-27	101	0

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