Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Health Line International Corporation · Predicate Candidate Screening

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

107 daysmedian FDA review time
288 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K261950Health Line Tearaway IntroducerHealth Line International Corporation2026-06-22120
K222170Power Acute Triple Lumen Hemodialysis CatheterHealth Line International Corporation2023-01-131760
K200426Acute Dual Lumen Hemodialysis CatheterHealth Line International Corporation2020-12-243070
K200263Health Line CT Midline CatheterHealth Line International Corporation2020-03-12380
K192533Health Line CT CVCHealth Line International Corporation2019-12-10850
K160448ARTLINEHealth Line International Corporation2016-07-121450
K140270NEXUS MIDLINE CT CATHETERHealth Line International Corporation2014-08-201980
K130851CASCADE HEMODIALYSIS/APHERESIS CATHETERHealth Line International Corporation2014-01-092880
K130034UNI-PICCHealth Line International Corporation2013-03-08600
K120548HLIC NEEDLE-LESS VALVEHealth Line International Corporation2012-05-04710
K101329SYNERGY CT PICCHealth Line International Corporation2010-08-19990
K060352HEALTH LINE INTERNATIONAL CORPORATIONS,S IV ADMINISTRATIVE SHealth Line International Corporation2006-05-311070

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