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

Litton Datamedix — Predicate Candidate Screening

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

84 daysmedian FDA review time

206 days90th percentile

5clearances measured

K-number	Device	Applicant	Decided	Review days
K853599	LITTON DATAMEDIX BLOOD PRESSURE MONITOR NI	Litton Datamedix	1986-03-21	206
K850290	ULTRASOUND GEL	Litton Datamedix	1985-04-18	84
K842497	SERVOMED OXYMONITO SMK 363	Litton Datamedix	1984-10-04	100
K842235	SERVOCARD DEFIBRILLATOR SCP-851	Litton Datamedix	1984-08-27	83
K842312	SERVOCARD SCP-840	Litton Datamedix	1984-08-27	76

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