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

GMT — Predicate Candidate Screening

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

107 daysmedian FDA review time

206 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K971502	SERODIA TP-PA	Scimedx Tekfile Services	1997-11-13	203
K911640	OLYMPUS PK TP(TM) SYSTEM, MODIFICATION	Olympus Corp.	1991-07-24	107
K911266	MODIFIED PK TP CONTROL	Olympus Corp.	1991-05-07	53
K905038	OLYMPUS PK-TP ABSORBENT KIT	Fujirebio America, Inc.	1991-05-06	181
K896410	CELLOGNOST SYPHILIS H	Behring Diagnostics, Inc.	1990-05-15	189
K893124	OLYMPUS PK(TM) TP	Fujirebio Diagnostics,Inc.	1989-11-17	206
K791897	BACTO-HATTS	Difco Laboratories, Inc.	1979-11-13	49
K791457	AGGLUTINOTEST-SYPHILIS	Volu Sol Medical Industries	1979-09-24	49
K760098	REAGENT, VDRL	Gamma Biologicals, Inc.	1976-08-03	50

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