Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

GOK — Predicate Candidate Screening

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

41 daysmedian FDA review time

90 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K832228	RUBASCAN LATEX CARD TEST	Bd Becton Dickinson Vacutainer Systems Preanalytic	1983-09-29	80
K810835	RUBAZYME - M	Abbott Laboratories	1981-05-05	41
K792635	ANTIBODY TO RUBELLA VIRUS	Electro-Nucleonics Laboratories, Inc.	1980-03-19	91
K792133	RUBELISA TEST KIT	Microbiological Assoc.	1980-01-11	81
K790122	RUBANON	Organon, Inc.	1979-02-15	23
K781638	RUBINDEX*DIRECT SYSTEM	Ortho Diagnostics, Inc.	1978-12-20	90
K781392	CYTOMEGILISH TEST KIT	Microbiological Assoc.	1978-10-24	75
K780010	GOAT ANTI-RUBELLA ANTISERA	Northeast Biomedical Labs., Inc.	1978-01-20	17
K780063	RUBENOSTICON	Organon, Inc.	1978-01-20	8
K771956	HUMAN O BUFFER	Flow Laboratories, Inc.	1977-10-28	11
K771957	RUBELLA HEMAGGLUTINATION REAGENT KIT	Flow Laboratories, Inc.	1977-10-28	11

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