Hemostasis, LLC: FDA clearances and approvals
Hemostasis, LLC has 10 FDA 510(k) clearances (first 2007, latest 2024), across 6 product codes in 3 review panels. Median 510(k) review time: 136 days. Since 2017 its median was 283 days, against 190 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 86 |
| 2013 | 1 | 223 |
| 2014 | 0 | — |
| 2015 | 1 | 154 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 2 | 366 |
| 2023 | 0 | — |
| 2024 | 1 | 211 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Hemostasis, LLC's cleared 510(k)s took a median 283 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 190 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QSY | Hemostatic Wound Dressing Without Thrombin Or Other Biologics | 5 | 5 |
| EMX | Balloon, Epistaxis | 1 | 1 |
| LYA | Splint, Intranasal Septal | 1 | 1 |
| MTJ | Wax, Bone | 1 | 1 |
| NHB | Polymer, Ear, Nose And Throat, Synthetic, Absorbable | 1 | 1 |
| QAU | Hemostatic Device For Endoscopic Gastrointestinal Use | 1 | 1 |
Review panels
Most recent Hemostasis, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K234131 | Resolv Endoscopic Hemostat System | QAU | 2024-07-26 | 211 |
| K220326 | PosiSep X BAM Hemostat Dressing/Intranasal Splint | EMX | 2022-11-14 | 283 |
| K210411 | PosiSep EAR Fragmentable Ear Dressing | NHB | 2022-05-05 | 448 |
| K142348 | OsteoSeal Bone Hemostat | MTJ | 2015-01-23 | 154 |
| K122494 | POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT | LYA | 2013-03-27 | 223 |
| K122886 | NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING | QSY | 2012-11-15 | 56 |
| K120958 | POSISEP AND POSISEP X HEMOSTAT DRESSINGS | QSY | 2012-07-25 | 117 |
| K102459 | NEXSTAT (TM) TOPICAL HEMOSTAT POWDER; NEXFOAM (R) TOPICAL SPONGE | QSY | 2010-12-03 | 98 |
| K072900 | EXCELARREST FOAM | QSY | 2007-10-26 | 15 |
| K070211 | TRAUMARREST AND BLEEDARREST HEMOSTATIC PARTICLES AND FOAM | QSY | 2007-04-05 | 73 |
Recalls
openFDA lists no recalls under a recalling firm named Hemostasis, LLC.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Hemostasis, LLC have?
Hemostasis, LLC has 10 FDA 510(k) clearances (first 2007, latest 2024), across 6 product codes in 3 review panels.
How long does FDA take to clear Hemostasis, LLC's 510(k)s?
The median time from FDA receipt to decision across Hemostasis, LLC's cleared 510(k)s is 136 days. Since 2017: 283 days, versus 190 days for all cleared 510(k)s in the same product codes.
What devices does Hemostasis, LLC make?
Its most frequent FDA product codes are QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics, 5); EMX (Balloon, Epistaxis, 1); LYA (Splint, Intranasal Septal, 1).
Has Hemostasis, LLC had device recalls?
openFDA lists no recalls under a recalling firm name matching Hemostasis, LLC. Related entities may recall under other names.
Next steps
- See all 10 Hemostasis, LLC clearances with predicates and recalls
- Run predicate analysis for product code QSY, Hemostasis, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.