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

GKR — Predicate Candidate Screening

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

77 daysmedian FDA review time

261 days90th percentile

39clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K201217	HemoCue Hb 301 System	Hemocue AB	2020-08-04	90	0
K200909	Hemo Control (optional Add Pack Hemo Control DM)	Ekf-Diagnostic GmbH	2020-06-12	67	0
K181751	HemoCue Hb 801 System	Hemocue AB	2019-02-01	214	0
K182298	hemochroma PLUS System	Immunostics Inc.,	2018-11-16	84	0
K172173	DiaSpect Tm, DiaSpect Tm Cuvettes	Ekf-Diagnostic GmbH	2018-04-06	261	0
K163465	hemochroma PLUS System	Immunostics Inc.,	2017-09-08	270	0
K122553	MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM	ACON Laboratories, Inc.	2013-08-05	349	0
K121752	AVIE TOTAL HB TEST SYSTEM	Mec Dynamics Corp	2013-01-07	207	0
K110393	EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM;	Ekf-Diagnostic GmbH	2011-03-04	21	0
K090093	STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SY	Stanbio Laboratory	2009-06-10	147	0
K081719	STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTE	Stanbio Laboratory	2008-07-18	30	0
K061047	HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MOD	Hemocue AB	2006-06-08	55	0
K041234	HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM	Hemocue, Inc.	2004-06-10	31	1
K032482	STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTE	Stanbio Laboratory	2003-10-24	73	0
K031898	EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM	Ekf Diagnostic GmbH	2003-09-24	97	0
K032203	HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704	Hemocue, Inc.	2003-08-25	38	1
K023561	ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM	International Technidyne Corp.	2003-01-31	100	0
K020710	BIOTEST HEMOGLOBIN MEASURING SYSTEM	Biotest Medizintechnik GmbH	2002-08-14	162	0
K020616	BAYER RAPIDPOINT 405 SYSTEM	Bayer Diagnostics Corp.	2002-07-17	142	2
K961312	HEMOCUE B-HEMOGLOBIN SYSTEM	Hemocue, Inc.	1996-09-24	173	0
K945677	IL682, CO-OXIMETER	Instrumentation Laboratory CO	1995-10-20	336	0
K954018	AVL OMNI ANALYZER	Avl Scientific Corp.	1995-10-05	41	8
K910745	HEMOGLOBIN REAGENT	Toa Medical Electronics USA, Inc.	1991-07-11	140	0
K880353	CIBA CORNING MODEL 280 PH/BLOOD GAS SYSTEM	Ciba Corning Diagnostics Corp.	1988-06-15	141	0
K870210	CLEARVIEW CW-10	Clearview Instruments, Inc.	1987-04-28	98	0
K865055	DR.BRUNO LANGE MINI-HBA1 PHOTOMETER	Diversa Corp.	1987-03-19	85	0
K850096	LASER-GLOBIN	Hematology Marketing Assoc.	1985-03-29	77	0
K850094	LASER-GLOBIN POWDER	Hematology Marketing Assoc.	1985-03-29	77	0
K841057	HEMOGLOBIN REAGENT SET	Medical Specialties, Inc.	1984-03-23	11	0
K832020	HEMOCUE PHOTOMETER TECHNICAL MANUAL	Aktiebolaget Leo Diagnostics	1983-10-28	135	0
K831618	HEMOGLOBIN REAGENT	Omega Medical Diagnostics	1983-06-16	28	0
K812127	KING DIAGNOSTICS HEMOGLOBIN TEST	King Diagnostics, Inc.	1981-08-25	29	0
K803016	HELENA HEMESPEC II TOTAL HEMOGLOBIN MET.	Helena Laboratories	1980-12-30	32	0
K803015	HEMESPEC II	Helena Laboratories	1980-12-30	32	0
K802266	HGB3 (1:251)	R&D Systems, Inc.	1980-10-23	37	0
K790030	FLUID, RHEMOX-HB LYSING	Sysmex Corp.	1979-02-08	36	0
K781361	HEMOGLOBINOMETER MODEL 720 B	Innovative Medical Systems, Inc.	1978-09-14	38	0
K780829	SYSING AND HEMOGLOBIN REAGENT	Harleco	1978-06-22	34	0
K771789	BLANKING SOLUTION HGB	J.T. Baker Chemical Co.	1977-10-07	17	0

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