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

Irvine Scientific — Predicate Candidate Screening

16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

74 daysmedian FDA review time

281 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days
K160006	Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification	Irvine Scientific	2016-05-04	121
K914541	SPERM MAINTENANCE MEDIUM WITH GLYCEROL	Irvine Scientific	1994-02-03	846
K900316	MODIFIED HAM'S F-10 MEDIUM AND MEDIUM-HEPES	Irvine Scientific	1990-04-16	83
K894432	MODIFIED HAM'S F-10 W/ALBUMIN	Irvine Scientific	1989-09-22	67
K894405	HTF WITH ALBUMIN (CATALOG NO. 9994)	Irvine Scientific	1989-09-22	67
K874668	SPERM WASHING MEDIUM #9983 & MODIFIED #9984	Irvine Scientific	1988-03-31	139
K872088	FREEZING MEDIUM (TEST YOLK BUFFER W/GLYCEROL)	Irvine Scientific	1987-08-14	74
K872203	CAT. #9972 REFRIGERATION MEDIUM (TEST YOLK BUFFER)	Irvine Scientific	1987-08-14	67
K872102	SPERM WASHING MEDIUM #9932	Irvine Scientific	1987-07-16	45
K871577	HTF MEDIUM AND MODIFIED HTF MEDIUM-HEPES	Irvine Scientific	1987-07-15	83
K861188	SPERM CAPACITATION MEDIUM	Irvine Scientific	1987-01-06	281
K851820	SPINAL FLUID CONTROL	Irvine Scientific	1985-07-15	80
K821560	LEVEL II LIPID CONTROL	Irvine Scientific	1982-07-13	49
K821559	LEVEL I LIPID CONTROL	Irvine Scientific	1982-07-13	49
K821557	LEVEL I CONTROL SERUM	Irvine Scientific	1982-07-08	44
K821558	LEVEL II CONTROL SERUM	Irvine Scientific	1982-07-02	38

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