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

PPM — Predicate Candidate Screening

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

29 daysmedian FDA review time

70 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days
K871533	TOMTEC GRAM STAINER DECOLORIZER	Remel Co.	1987-04-29	9
K863550	POTASSIUM HYDROXIDE 10% W/V	Reagent Laboratory, Inc.	1986-10-02	20
K861890	100%, 95%, 80% & 70% DEHYDRANT CUSTOM BLEND NO. 2	Richard-Allan Medical Ind., Inc.	1986-06-03	18
K850916	SPRAYFIX	Surgipath Medical Industries, Inc.	1985-03-25	20
K850737	TRANSPORT CULTURE MEDIUM	Roseville Medical Laboratoriesu	1985-03-20	28
K850845	0.85% SALINE	Micro Media Laboratories	1985-03-20	19
K842934	DECOLORIZING FLUIC, ACID-ALCOHOL 3%	E K Ind., Inc.	1984-09-12	49
K842863	PRO-SOFT DEHYDRANT	Anatech, Ltd.	1984-08-21	29
K842729	DECOLORIZING FLUID	E K Ind., Inc.	1984-08-03	21
K842070	IDD DETERGENT	Interscience Diagnostics, Inc.	1984-07-02	40
K831620	SODIUM HYPOCHLORITE 3%	Omega Medical Diagnostics	1983-07-28	70
K831619	SODIUM HYPOCHLORITE 7%	Omega Medical Diagnostics	1983-07-28	70
K822326	BLENDED DETERGENT-78N 1912-1	Interscience, Inc.	1982-10-18	76
K822037	VOLU-SOL TAP WATER SUBSTITUTE	Volu Sol Medical Industries	1982-08-03	22
K811800	BLUING REAGENT	Richard-Allan Medical Ind., Inc.	1981-08-12	49
K811796	FORMAL ALCOHOL	Richard-Allan Medical Ind., Inc.	1981-07-28	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