Atlas FDA

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

QOI · Predicate Candidate Screening

8 FDA 510(k) clearances under this product code; the 50 most recent screened below.

112 daysmedian FDA review time
617 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K241415Orchid Safety Release Valve™Linear Health Sciences, LLC2024-09-061120
K232094Orchid Safety Release ValveTMLinear Health Sciences, LLC2023-10-03820
K231957SafeBreak® VascularLineus Medical2023-09-29880
K223486SafeBreak® VascularLineus Medical2023-05-191790
K230266Orchid Safety Release ValveLinear Health Sciences, LLC2023-05-04930
K222791SafeBreak VascularLineus Medical, LLC2022-10-16310
K212064Orchid Safety Release Valve(TM)Linear Health Sciences, LLC2022-05-033050
DEN190043SafeBreak VascularSite Saver, Inc. D/B/A Lineus Medical2021-05-276170

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