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

Jolife AB — Predicate Candidate Screening

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

84 daysmedian FDA review time

135 days90th percentile

5clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K173553	LUCAS 3 Chest Compression System	Jolife AB	2018-02-08	84	0
K161768	LUCAS 3 Chest Compression System	Jolife AB	2016-11-09	135	2
K090422	LUCAS 2	Jolife AB	2009-06-17	119	3
K062401	MODIFICATION TO LUCAS	Jolife AB	2006-09-28	43	0
K053403	LUCAS	Jolife AB	2006-02-01	57	0

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