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

JRE — Predicate Candidate Screening

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

238 daysmedian FDA review time

273 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K954977	URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION)	Teco Diagnostics	1996-03-11	147
K941901	MODEL 2721 CLINICAL REFRACTOMETER	Vee Gee Scientific, Inc.	1995-01-17	273
K941906	MODEL 2730 CLINICAL REFRACTOMETER	Vee Gee Scientific, Inc.	1995-01-17	273
K941903	MODEL 2740 CLINICAL REFRACTOMETER	Vee Gee Scientific, Inc.	1995-01-17	273
K941905	MODEL 3461 CLINICAL REFRACTOMETER	Vee Gee Scientific, Inc.	1994-12-13	238
K941902	MODEL 3471 CLINICAL REFRACTOMETER	Vee Gee Scientific, Inc.	1994-12-13	238
K941904	MODEL A300CL CLINICAL REFRACTOMETER	Vee Gee Scientific, Inc.	1994-12-13	238
K891681	DILECTRON URINARY CONDUCTIVITY PROBE	Gyrus Medical , Ltd.	1990-05-01	405
K842168	ATAGO URINE SPECIFIC GRAVITY & SERUM	Kyoto Diagnostics, Inc.	1984-07-16	46
K831213	SPECIFIC GRAVITY INSTRUMENT	Iris	1983-06-30	77
K811342	REAGENT STRIPS FOR URINALYSIS	Miles Laboratories, Inc.	1981-09-01	112
K802959	NIKON URINE REFRACTOMER SG-1	Nippon Kogaku, Inc.	1980-12-19	29
K790862	BIOVATION DIGITAL URINOMETER	Biovation, Inc.	1979-06-28	52

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