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

Litton Bionetics — Predicate Candidate Screening

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

84 daysmedian FDA review time

105 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K840417	EBNA ACIF KIT	Litton Bionetics	1984-12-27	331
K834443	ROTAVIRUS BIO-ENZABEAD SCREEN KIT	Litton Bionetics	1984-03-16	91
K831343	CMV RQ BIO-ENZABEAD KIT	Litton Bionetics	1983-08-08	105
K822985	EBV-M KIT	Litton Bionetics	1982-12-03	52
K821804	RUBELLA RQ BIO-ENZABEAD KIT	Litton Bionetics	1982-09-14	89
K801722	CMV BIO-BEAD TITRATION KIT	Litton Bionetics	1980-09-16	55
K801721	HSV BIO-BEAD TITRATION KIT	Litton Bionetics	1980-09-16	55
K801720	TOXO BIO-BEAD TITRATION KIT	Litton Bionetics	1980-09-16	55
K800789	RUBELLA BIO-BEAD TITRATION KIT	Litton Bionetics	1980-06-30	83
K791610	RUBELLA BIO-BEAD SCREEN KIT	Litton Bionetics	1979-11-13	84
K791614	HSV BIO-BEAD SCREEN KIT	Litton Bionetics	1979-11-13	84
K791618	TORCH BIO-BEAD SCREEN KIT	Litton Bionetics	1979-11-13	85
K791611	TOXO BIO-BEAD SCREEN KIT	Litton Bionetics	1979-11-13	84
K791612	CMV BIO-BEAD SCREEN KIT	Litton Bionetics	1979-11-13	84
K780925	EB-VCA, TEST, ANTIBODY, FLUORESCENT	Litton Bionetics	1978-06-22	16

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