Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
QSY — Predicate Candidate Screening
127 FDA 510(k) clearances under this product code; the 50 most recent screened below.
154 daysmedian FDA review time
337 days90th percentile
127clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253017 | BloodSTOP iX Trauma Matrix (TM-iX-20) | Lifescience Plus, Inc. | 2026-04-30 | 223 | 0 |
| K251700 | Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG1004 | Speciality Fibres and Materials Limited | 2026-02-26 | 269 | 0 |
| K250319 | MFUSE (MS001) | Machina Medical, Inc. | 2025-12-15 | 314 | 0 |
| K253609 | TRAUMAGEL® 2.0 Hemostatic Gel | Cresilon, Inc. | 2025-12-12 | 24 | 0 |
| K240713 | TRAUMAGEL® | Cresilon, Inc. | 2024-08-14 | 152 | 0 |
| K240097 | Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5) | Ushare Medical, Inc. | 2024-05-22 | 131 | 0 |
| K232216 | Hemoblock_S (Prescription); Hemoblock_S (OTC) | Incore Co., Ltd. | 2024-04-19 | 268 | 0 |
| K240454 | RESPONDER® Polysaccharide Hemostat | Starch Medical, Inc. | 2024-03-15 | 29 | 0 |
| K220525 | RESPONDER Polysaccharide Hemostat | Starch Medical, Inc. | 2023-12-04 | 649 | 0 |
| K230589 | Celox Rapid X-Ray Gauze | Medtrade Products , Ltd. | 2023-11-17 | 260 | 0 |
| K213413 | Hemostatic Dressing | Jiangsu Newvalue Medical Products Co., Ltd. | 2023-09-01 | 682 | 0 |
| K213652 | Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG) | Cresilon, Inc. | 2023-06-28 | 586 | 0 |
| K223495 | Zeolite Hemostatic Cotton | Hangzhou Zeo-Innov Life Technology Co., Ltd. | 2023-05-02 | 162 | 0 |
| K222909 | Axiostat Gauze | Advamedica, Inc. | 2023-04-07 | 193 | 0 |
| K210751 | S.E.A.L. Hemostatic Wound Spray | Bc3 Technologies, Inc. | 2023-02-02 | 692 | 0 |
| K220566 | Vascette HP (hemostatic pad) | Koag, LLC | 2022-07-29 | 151 | 0 |
| K211570 | Zeolite Hemostatic Gauze | Hangzhou Zeo-Innov Life Technology Co., Ltd. | 2022-02-10 | 265 | 0 |
| K202830 | Axiostat Patch | Advamedica, Inc. | 2021-04-15 | 202 | 0 |
| K192671 | Hemostatic Xerogel Sponge | Solaplus Biotech Co., Ltd. | 2020-08-28 | 337 | 0 |
| K190012 | OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid | Medtrade Product, Ltd. | 2019-12-18 | 349 | 0 |
| K183622 | NasalCEASE and BleedCEASE | Les Laboratoires Brothier S.A. | 2019-12-02 | 341 | 0 |
| K192667 | gel-e Flex+ gel OTC | Gel-E, Inc. | 2019-10-25 | 30 | 0 |
| K182811 | gel-e Flex+ | Gel-E, Inc. | 2019-08-29 | 330 | 0 |
| K181641 | QuikClot Radial | Z-Medica, LLC | 2018-12-24 | 186 | 0 |
| K180893 | IHM Technology Bandage | Protege Biomedical | 2018-09-19 | 167 | 0 |
| K180152 | gel-e Flex | Gel-E, Inc. | 2018-06-22 | 154 | 0 |
| K172155 | StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing | Statguard, LLC | 2018-04-12 | 269 | 0 |
| K172324 | Axiostat Chitosan Hemostatic Dressing | Advamedica, Inc. | 2018-02-23 | 206 | 0 |
| K161274 | Bondiloxs Topical Hemostatic Granules | Medtrade Products , Ltd. | 2017-01-18 | 257 | 0 |
| K161013 | InnoSEAL Hemostatic Pad | Innotherapy, Inc. | 2016-11-29 | 232 | 0 |
| K160679 | WoundClot9 | Core Scientific Creation , Ltd. | 2016-08-08 | 151 | 0 |
| K160130 | BloodSTOP iX Battle Matrix | Lifescience Plus, Inc. | 2016-06-29 | 161 | 0 |
| K160578 | Nustat XR | Beeken Biomedical, LLC | 2016-06-29 | 120 | 0 |
| K153582 | Prometheus ChitoGauze XR PRO | Hem Con Medical Technologies, Inc. | 2016-05-25 | 162 | 0 |
| K150916 | HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemC | Hem Con Medical Technologies, Inc. | 2015-11-10 | 218 | 0 |
| K150963 | AnsCare ChitoClot Pad | Benq Materials Corporation | 2015-11-05 | 209 | 0 |
| K151204 | HEMO-Bandage | Coreleader Biotech Co., Ltd. | 2015-07-31 | 87 | 0 |
| K143466 | Hemogrip Patch | Remedium Technologies, Inc. | 2015-06-08 | 186 | 0 |
| K143462 | AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClo | Benq Materials Corporation | 2015-05-08 | 155 | 0 |
| K142363 | NUSTAT, NUSTAT XR | Beeken Biomedical | 2015-01-09 | 137 | 0 |
| K140573 | WOUNDCLOT HEMOSTATIC GAUZE | Core Scientific , Ltd. | 2014-11-24 | 263 | 0 |
| K140313 | STOPSBLEEDING TOPICAL HEMOSTAT POWDER AND FOAM | Coag Medical, LLC | 2014-07-28 | 168 | 0 |
| K140757 | D2 HEMOSTANTIC DRESSING | Z-Medica, LLC | 2014-07-17 | 113 | 0 |
| K132333 | BONDILOXS TOPICAL HEMOSTATIC DRESSING | Medtrade Products , Ltd. | 2014-06-25 | 334 | 0 |
| K133121 | CHITO-SAM 100,4IN X4IN,CHITO-SAM, 3IN X6FT, CHITO-SAM 100,3I | Sam Medical Products | 2014-05-22 | 234 | 0 |
| K132105 | PERCLOT TOPICAL | Cryolife, Inc. | 2014-04-03 | 269 | 0 |
| K130324 | STATSEAL DISC | Biolife, LLC | 2013-07-09 | 151 | 0 |
| K123387 | QUIKCLOT HEMOSTATIC DRESSING | Z-Medica, LLC | 2013-04-12 | 161 | 0 |
| K120782 | INTERVENTIONAL HEMOSTATIC BANDAGE | Z-Medica Corporation | 2013-03-20 | 370 | 0 |
| K122886 | NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING | Hemostasis, LLC | 2012-11-15 | 56 | 0 |
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