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

Johnson & Johnson — Predicate Candidate Screening

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

83 daysmedian FDA review time

240 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K113273	SPOTLIGHT ACCESS SYSTEM	Johnson & Johnson	2012-01-27	81
K112913	SPOTLIGHT ACCESS SYSTEM	Johnson & Johnson	2011-12-16	74
K113348	COUGAR SYSTEM	Johnson & Johnson	2011-12-13	29
K110551	EXPEDIUM SPINE SYSTEM	Johnson & Johnson	2011-10-26	240
K110694	CONCORDE BULLET SPINAL SYSTEM	Johnson & Johnson	2011-10-11	211
K111571	VIPER SYSTEMS	Johnson & Johnson	2011-07-06	30
K110454	COUGAR LS LATERAL CAGE SYSTEM	Johnson & Johnson	2011-05-13	86
K103743	CONCORDE CURVE SYSTEM	Johnson & Johnson	2011-03-17	84
K103490	EXPEDIUM SPINE SYSTEM, MOSS MIAMI SPINE SYSTEM	Johnson & Johnson	2011-02-17	83

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