Atlas FDA

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

QLY · Predicate Candidate Screening

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

178 daysmedian FDA review time
207 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K251849StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaCStaclear, Inc.2025-11-211580
K243322Altaviz Intravitreal SyringeAltaviz, LLC2025-05-091980
K243027Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHHangzhou Sightnovo Medical Technology Co., Ltd.2025-04-081930
K243936StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaCStaclear, Inc.2025-04-031040
K243149Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microCongruence Medical Solutions, LLC2024-12-20810
K230372VitreJect SyringeOcuject, LLC2023-09-082070
K200242StaClear SyringeTribofilm Research, Inc.2020-07-271780

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