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

JQY · Predicate Candidate Screening

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

67 daysmedian FDA review time

164 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K952178	PH-DETECT TEST	Diagnostic Reagents, Inc.	1995-10-20	164
K905146	OLYMPUS URINE PH	Diagnostic Systems	1991-02-04	81
K872888	CIBA CORNING 288 PH/BLOOD GAS SYSTEM	Ciba Corning Diagnostics Corp.	1987-08-25	33
K770347	METER, PH, DIGITAL, MODEL 3560	Beckman Instruments, Inc.	1977-04-15	52
K770352	METER, IV PH, MODEL EXPANDOMATIC	Beckman Instruments, Inc.	1977-04-08	45
K770351	METER, IV PH, MODEL ZEROMATIC	Beckman Instruments, Inc.	1977-04-05	42
K760789	PH METER-130 (.001 PH)	Corning Medical & Scientific	1976-11-16	67
K760788	PH METER-125 (.01 PH)	Corning Medical & Scientific	1976-11-16	67

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