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

KIS — Predicate Candidate Screening

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

19 daysmedian FDA review time

49 days90th percentile

45clearances measured

K-number	Device	Applicant	Decided	Review days
K881287	ANIMAL AND HUMAN SERA	Cell Culture Laboratories	1988-04-05	8
K880471	BOVINE CALF SERUM SUPPLEMENTED #A-2159	Hyclone Laboratories, Inc.	1988-04-04	61
K880470	BOVINE CALF SERUM CATALOG #A-2119	Hyclone Laboratories, Inc.	1988-04-01	58
K872847	SOLCOSERYL TISSUE CULTURE GROWTH SUPPLEMENT	Candace Lane Corp.	1987-08-10	21
K870580	MLC NORMAL SERUM	Rjo Biologicals, Inc.	1987-04-08	56
K870938	FETAL BOVINE SERUM	Hyclone Laboratories, Inc.	1987-03-31	22
K870467	DEFINED CALF BOVINE SERUM SUPPLEMENTED #A-2151	Hyclone Laboratories, Inc.	1987-03-24	49
K870464	CHARACTERIZED FETAL BOVINE SERUM #A-1115	Hyclone Laboratories, Inc.	1987-03-24	49
K870468	ADULT BOVINE SERUM	Hyclone Laboratories, Inc.	1987-03-24	49
K870463	DEFINED FETAL BOVINE SERUM #A-1111	Hyclone Laboratories, Inc.	1987-03-24	49
K870466	DEFINED CALF BOVINE SERUM #A-2111	Hyclone Laboratories, Inc.	1987-03-24	49
K870465	6/40 FETAL BOVINE SERUM #A-1110	Hyclone Laboratories, Inc.	1987-03-24	49
K870469	DEFINED EQUINE SERUM #A-3311	Hyclone Laboratories, Inc.	1987-03-24	49
K861810	CHICKEN SERUM - STERILE FILTERED	Hazleton Research Products, Inc.	1986-05-20	11
K861813	HUMAN AB SERUM - STERILE FILTERED	Hazleton Research Products, Inc.	1986-05-20	11
K861812	HUMAN SERUM - STERILE FILTERED	Hazleton Research Products, Inc.	1986-05-20	11
K861815	BOVINE BLOOD CELLS IN ALSEVERS CITRATE/DEFIBRINATE	Hazleton Research Products, Inc.	1986-05-20	11
K861816	MOUSE BLOOD CELLS IN ALSEVERS OR CITRATE	Hazleton Research Products, Inc.	1986-05-20	11
K861809	LAMB SERUM - STERILE FILTERED	Hazleton Research Products, Inc.	1986-05-20	11
K861814	RHESUS MONKEY SERUM - STERILE FILTERED	Hazleton Research Products, Inc.	1986-05-20	11
K861817	HORSE BLOOD CELLS IN ALSEVERS CITRATE/DEFIBRINATED	Hazleton Research Products, Inc.	1986-05-20	11
K861811	MOUSE SERUM - STERILE FILTERED	Hazleton Research Products, Inc.	1986-05-20	11
K860762	GAMMA-FREE HORSE SERUM	Flow Laboratories, Inc.	1986-03-10	10
K860752	GOAT SERUM (29-391-54)	Flow Laboratories, Inc.	1986-03-10	10
K853803	FETAL BOVINE/FETAL CALF SERUM, NEWBORN, HORSE, RAB	Z.L. Bocknek Laboratories, Inc.	1985-10-15	34
K843629	FETAL BOVINE SERUM, F4884 STERILE GROWT	Sigma Chemical Co.	1984-10-01	17
K833463	CLEX	Dextran Products, Ltd.	1983-11-21	47
K812384	NEWBORN CALF SERUM - STERILE	Dutchland Laboratories, Inc.	1981-09-08	19
K812385	NATAL CALF (BOVINE) SERUM - STERILE	Dutchland Laboratories, Inc.	1981-09-08	19
K812381	DONOR HORSE SERUM - STERILE	Dutchland Laboratories, Inc.	1981-09-08	19
K812383	CALF (BOVINE) SERUM - STERILE	Dutchland Laboratories, Inc.	1981-09-08	19
K812386	FETAL BOVINE SERUM - STERILE	Dutchland Laboratories, Inc.	1981-09-08	19
K812380	RABBIT SERUM - STERILE	Dutchland Laboratories, Inc.	1981-09-08	19
K812379	GUINEA PIG SERUM - STERILE	Dutchland Laboratories, Inc.	1981-09-08	19
K812382	DONOR CALF (BOVINE-SERUM) - STERILE	Dutchland Laboratories, Inc.	1981-09-08	19
K812329	ZETA-SERA D	Amf Biological and Diagnostics Co.	1981-09-01	14
K810775	GOAT SERUM-STERILE	Dutchland Laboratories, Inc.	1981-05-08	46
K810874	FETAL CALF SERUM	Tissue Culture Biologicals	1981-04-23	23
K810903	NEWBORN BOVINE SERUM	Biolabs, Inc.	1981-04-14	11
K810904	BOVINE CALF SERUM	Biolabs, Inc.	1981-04-14	11
K810478	ANIMAL SERUM PRODUCTS	Animal Health Laboratories, Inc.	1981-04-08	44
K810268	NORMLCERA	Medical Specialties Laboratories	1981-03-06	32
K802418	FETAL BOVINE SERUM	S&S Biologicals	1980-10-31	25
K800781	FETAL BOVINE SERUM	Biolabs, Inc.	1980-04-21	13
K780009	GUINEA PIG WHOLE SERUM	Northeast Biomedical Labs., Inc.	1978-01-20	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