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

GIF — Predicate Candidate Screening

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

40 daysmedian FDA review time

94 days90th percentile

38clearances measured

K-number	Device	Applicant	Decided	Review days
K883989	KVM ISOTONIC FLUSH SOLUTION	Kvm Technologies, Inc.	1988-10-12	22
K883990	KVM ISOTONIC DILUENT	Kvm Technologies, Inc.	1988-10-12	22
K882490	HYCEL QUICK-LYSING HEMOGLOBIN REAGENT	R&D Systems, Inc.	1988-07-25	39
K882267	SYSMEX QUICKLYSER-II (QLS-200A)	Toa Medical Electronics USA, Inc.	1988-07-12	42
K881130	CELL-DYN ISOTONIC DILUENT	Abbott Diagnostics	1988-03-31	15
K873347	CELL-DYN DIFF. SCREEN ISOTONIC DILUENT	Abbott Diagnostics	1987-09-09	20
K851843	OSMOCEL 3	Hematology Marketing Assoc.	1985-07-30	95
K851320	SDI PREPAX DILUKIT M.	Scientific Distributors, Inc.	1985-07-05	94
K851280	DASS PACK	Dass, Inc.	1985-07-05	95
K850239	SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT-	Toa Medical Electronics USA, Inc.	1985-04-01	69
K850095	LASER-DIL	Hematology Marketing Assoc.	1985-03-29	77
K844782	NSI ELT-D DILUTING FLUID 4000ML	Nobel Scientific Industries, Inc.	1985-03-05	85
K842929	HAYEM DILUTING FLUID	E K Ind., Inc.	1984-09-07	44
K842068	IDI ISOTONIC DILUENT	Interscience Diagnostics, Inc.	1984-07-02	40
K841799	CYANOMETHEMOGLOBIN REAGENT	Reagent Laboratory, Inc.	1984-05-31	43
K840477	UNITIZED HEMATOLOGY SET 65132/93	Emd Chemicals, Inc.	1984-03-05	31
K840041	SDI PREPAX DILUKIT HW	Scientific Distributors, Inc.	1984-03-05	59
K833972	QUICK-COUNT HEMATOLOGY REAGENT KIT	Seragen Diagnostics, Inc.	1984-02-17	93
K840038	PREPAX DILUKIT PLUS	Scientific Distributors, Inc.	1984-02-10	36
K840043	SDI PREPAX DILUKIT CT	Scientific Distributors, Inc.	1984-02-10	35
K833443	ISOTONIC BLOOD CELL DILUENT J & S	Jasins & Sayles Associates, Inc.	1983-11-03	29
K832116	ATAC 4700 HEMATOLOGY CELL COUNTER	Turpen Laboratory Systems, Inc.	1983-10-20	112
K831617	DILUENT	Omega Medical Diagnostics	1983-06-16	28
K830188	OSMOCEL +	Hematology Marketing Assoc.	1983-03-01	41
K822325	BLOOD CELL DILUENT 78N 1913	Interscience, Inc.	1982-10-18	76
K822501	CDL ISOTONIC DILUENT	Connecticut Diagnostics, Ltd.	1982-09-17	30
K821683	REAGENT FOR COULTER COUNTER MODEL 5+11	Fisher Scientific Co., LLC	1982-06-24	16
K812309	CRYOSAN NORMAL SALINE	Cryosan, Inc.	1981-09-16	30
K801357	MODIFIED BLOOD CELL COUNTING & LYSING	Coulter Electronics, Inc.	1980-08-14	66
K801346	NSI REAGENT SYSTEM FOR ORTHO ELT-8 HEMA	Nobel Scientific Industries, Inc.	1980-08-12	64
K800180	VARIOUS REAGENTS FOR BLOOD CELL ANALYZER	Laboratory Products, Inc.	1980-03-19	50
K790442	ISOTONIC DILUENT	Royco Instruments	1979-04-04	28
K790028	DILUENT, CELLENT BLOOD	Sysmex Corp.	1979-02-15	43
K781008	ISOTONIC DILUENT	Mallinckrodt Critical Care	1978-06-28	9
K780830	ISOTONIC BUFFERED SALINE	Harleco	1978-06-14	26
K771787	AZIDE FREE BLOOD DILUTING REAGENT	J.T. Baker Chemical Co.	1977-10-07	17
K760129	SALINE, ISOTONIC BUFFERED, AZIDE-FREE	Harleco	1976-07-20	22
K760124	AUTO CELL DILUENT	Bd Becton Dickinson Vacutainer Systems Preanalytic	1976-07-20	22

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