Atlas FDA

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

Hemostasis, LLC — Predicate Candidate Screening

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

154 daysmedian FDA review time
448 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K234131Resolv Endoscopic Hemostat SystemHemostasis, LLC2024-07-262110
K220326PosiSep X BAM Hemostat Dressing/Intranasal SplintHemostasis, LLC2022-11-142830
K210411PosiSep EAR Fragmentable Ear DressingHemostasis, LLC2022-05-054480
K142348OsteoSeal Bone HemostatHemostasis, LLC2015-01-231540
K122494POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINTHemostasis, LLC2013-03-272230
K122886NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSINGHemostasis, LLC2012-11-15560
K120958POSISEP AND POSISEP X HEMOSTAT DRESSINGSHemostasis, LLC2012-07-251170
K102459NEXSTAT (TM) TOPICAL HEMOSTAT POWDER; NEXFOAM (R) TOPICAL SPHemostasis, LLC2010-12-03980
K072900EXCELARREST FOAMHemostasis, LLC2007-10-26150
K070211TRAUMARREST AND BLEEDARREST HEMOSTATIC PARTICLES AND FOAMHemostasis, LLC2007-04-05730

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