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

LCH — Predicate Candidate Screening

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

37 daysmedian FDA review time

111 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K922386	RNA MEDICAL TONOMETER	Bionostics, Inc.	1992-06-26	37
K904163	CLINICAL BLOOD GAS MIXTURES	Norco, Inc.	1990-11-01	51
K900819	BLOOD GAS CALIBRATION STANDARD	Cryogenic Rare Gas Laboratories, Inc.	1990-04-25	63
K862958	AMR RESEARCH TONOMETER	Associated Medical Representatives	1986-11-24	111
K841089	LINEAR CLOUD TONOMETER	Linear Tonometers, Inc.	1984-05-22	70
K802379	HEM-O-SCAN OXYGEN EQUIL. CURVE ANALYZER	American Instrument Co.	1980-10-31	31
K801599	CORNING 184 BLOOD GAS TONOMETER	Corning Medical & Scientific	1980-08-20	37
K781417	PRECISION GAS MIXER	Medicor USA , Ltd.	1978-09-20	35
K781386	EBS 775 TONOMETER	Equilibrated Bio Systems, Inc.	1978-09-14	34

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