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

KHG — Predicate Candidate Screening

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

47 daysmedian FDA review time

196 days90th percentile

39clearances measured

K-number	Device	Applicant	Decided	Review days
K221508	AnemoCheck Home	Sanguina, Inc.	2023-09-29	493
K163215	AnemoCheck	Sanguina, LLC	2017-09-13	301
K042379	ANEMIAPRO SELF-SCREENER	Biosafe Laboratories, Inc.	2004-12-15	105
K020138	STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT	Gds Technology	2002-02-11	26
K001462	CARESIDE HEMOGLOBIN	Careside, Inc.	2000-08-21	103
K994073	HEMOSITE TEST SYSTEM	Gds Technology, LLC	2000-01-14	43
K973649	HEMOSITE TEST SYSTEM	Gds Technology, LLC	1998-08-31	340
K953221	ABBOTT VISION HEMOGLOBIN (MODIFICATION)	Abbott Laboratories	1995-09-29	102
K934064	REFLOTRON HEMOGLOBIN TEST TABS	Boehringer Mannheim Corp.	1993-12-06	159
K895101	BIOTRACK HEMOGLOBIN TEST CARTRIDGE	Biotrack, Inc.	1989-10-10	56
K885227	CLINISTAT HEMOGLOBIN REAGENT TEST	Heraeus Kulzer, Inc.	1989-02-24	66
K880038	FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527	Sigma Diagnostics, Inc.	1988-04-21	107
K872653	EASY-TEST HEMOGLOBIN (HGB) ITEM #16685	Em Diagnostic Systems, Inc.	1987-07-23	16
K870363	HAEMOGLOBIN REAGENT - CYANMETHAEMOGLOBIN METHOD	Trace Scientific , Ltd.	1987-03-16	47
K863104	TOTAL HEMOGLOBIN	J. D. Assoc.	1986-09-04	21
K862641	U.S. DIAGNOSTIC INC. HEMOGLOBIN TEST (DRY PACK)	U. S. Diagnostics, Inc.	1986-08-21	41
K862202	VISION(TM) HEMOGLOBIN	Abbott Laboratories	1986-08-18	69
K854687	ERMA HB-METER MODEL 303N	Future Impex Corp.	1986-06-04	196
K860475	HEMOGLOBIN REAGENT SET	Sterling Diagnostics, Inc.	1986-03-03	24
K854139	KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE HB	Eastman Kodak Company	1985-11-05	26
K851467	HEMOGLOBIN ANALYZER	Awareness Technology, Inc.	1985-07-16	92
K851432	HEMOGLOBIN	Pointe Scientific, Inc.,	1985-07-12	93
K832750	EASYTOUCH HEMOGLOBIN REAGENT	Worthington Diagnostic Systems	1983-09-26	42
K831813	CO-OXIMETER CONTROL	United Diagnostics, Inc.	1983-07-28	52
K830180	REFEREE BRAND CO-OXIMETER REAGENTS	Analytical Products, Inc.	1983-04-08	80
K830590	CORNING 2500 CO-OXIMETER	Corning Medical & Scientific	1983-04-05	40
K823060	HEMOGLOBIN REAGENT	Biorent Diagnostic, Inc.	1982-11-22	35
K822044	SERALYZER HEMOGLOBIN REAGENT STRIPS	Miles Laboratories, Inc.	1982-07-30	18
K822045	SERALYZER HEMOGLOBIN TEST MODULE	Miles Laboratories, Inc.	1982-07-30	18
K821658	HEMOGLOBIN REAGENT	Anco Medical Reagents & Assoc.	1982-06-25	21
K820596	CYANMETHEMOGLOBIN TEST	Boehringer Mannheim Corp.	1982-03-26	22
K803248	AMES SERA-PAK HEMOGLOBIN REAGENT	Miles Laboratories, Inc.	1981-01-26	34
K802268	CRC(CYANMETHEMOGLOBIN REAGENT CONCENT	R&D Systems, Inc.	1980-12-31	106
K802569	ABNORMAL HEMOGLOBIN CONTROL	Marilyn L. Amick	1980-11-12	26
K802568	HEMOGLOBIN CONTROL	Marilyn L. Amick	1980-11-12	26
K801268	HEMOGLOBIN CONTROL LEVELS	Bioscientific	1980-07-14	47
K800059	COMPUR M-1000 MINI-PHOTOMETER	Miles Laboratories, Inc.	1980-04-04	85
K792503	SANDARE CYANMETHEMOGLOBIN REAGENT	Sandare Chemical Co., Inc.	1979-12-31	27
K760208	OXIMETER, CO-, IL MODEL 282	Instrumentation Laboratory CO	1976-07-26	17

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