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

GKG — Predicate Candidate Screening

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

78 daysmedian FDA review time

145 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K961803	SPUNCRIT (MODEL DRC-40)	Micro Diagnostics Corp.	1996-07-05	57
K955795	MULTI-CENTRIFUGE	Novonx, Inc.	1996-03-29	98
K930415	MICROHEMATOCRIT ROTOR	Fisher Scientific Co., LLC	1993-03-23	56
K925863	SPUNCRIT	bioMerieux, Inc.	1993-02-05	78
K920207	HERMLE Z230H	Labnet Intl., Inc.	1992-06-09	145
K920759	CRITSPIN MICRO-HEMATOCRIT	Stat-Spin Technologies	1992-04-29	70
K913128	HEMATASTAT C-70B	Separation Technology, Inc.	1991-09-23	136
K890849	HEMATASTAT H-70	Separation Technology, Inc.	1989-03-21	28
K822445	HCT CENTRIFUGE	Boehringer Mannheim Corp.	1982-09-14	29
K821803	QBC CENTRIFUGAL HEMATOLOGY SYSTEM	Bd Becton Dickinson Vacutainer Systems Preanalytic	1982-09-14	90
K813033	CLAY ADAMS QBC CENTRIFUGAL HEMOTOLOGY	Bd Becton Dickinson Vacutainer Systems Preanalytic	1982-04-09	163

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