Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
LHI — Predicate Candidate Screening
206 FDA 510(k) clearances under this product code; the 50 most recent screened below.
89 daysmedian FDA review time
282 days90th percentile
206clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252987 | ADRx™ Admixture Device | Epic Medical Pte. , Ltd. | 2026-06-12 | 267 | 0 |
| K260301 | Vial Adapter | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2026-06-05 | 126 | 0 |
| K250345 | Medline Bag Decanter | Medline Industries, LP | 2025-10-24 | 260 | 0 |
| K251715 | FlowArt® Vial Access Device Vented | Asset Medikal | 2025-10-14 | 132 | 0 |
| K251676 | Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medlin | Microtek Medical, LLC | 2025-09-16 | 109 | 0 |
| K243404 | HyHub™ and HyHub™ Duo Vial Access Devices | Takeda Pharmaceuticals | 2025-07-18 | 259 | 0 |
| K240761 | Arisure® Closed Male Luer with Spike Adapter (YM060) | Yukon Medical, LLC | 2025-03-21 | 366 | 0 |
| K243985 | Rio™ Drug Reconstitution Transfer Device | Icu Medical, Inc. | 2025-01-22 | 30 | 0 |
| K243486 | SmartSiteTM Vented Vial Access Device | Yukon Medical, LLC | 2024-12-06 | 28 | 0 |
| K241976 | nextaro® va, 15mm, 5µm | Sfm Medical Devices GmbH | 2024-09-06 | 63 | 0 |
| K233287 | Vent Vial Adapter | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2024-07-26 | 301 | 0 |
| K232987 | FlowArt Valve for Vial Access | Asset Medikal Tasarim Sanayi VE Ticaret A.S. | 2024-06-26 | 278 | 0 |
| K240940 | Vial2Bag Advanced® 20mm Admixture Device | West Pharmaceutical Services, Inc. | 2024-05-03 | 28 | 0 |
| K233284 | Vial Adapter with Filter | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2024-05-01 | 215 | 0 |
| K240748 | nextaro® v, 20/20 | Sfm Medical Devices GmbH | 2024-04-16 | 28 | 0 |
| K233021 | BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vi | Care Fusion | 2024-03-06 | 166 | 0 |
| K231071 | Mix2Vial® Transfer Device | West Pharma. Services IL, Ltd. | 2024-01-19 | 280 | 0 |
| K232875 | Vial Adapter 20mm | West Pharma. Services IL, Ltd. | 2023-12-14 | 90 | 0 |
| K230988 | Vial2Bag Advanced® 13mm Admixture Device | West Pharma. Services IL, Ltd. | 2023-12-01 | 239 | 0 |
| K232055 | Vial Adapter | Shanghai Lingfu Technology Co., Ltd. | 2023-10-06 | 87 | 0 |
| K230464 | MixJect® Transfer Device | West Pharma. Services IL, Ltd. | 2023-05-22 | 90 | 0 |
| K222718 | Vial Adapter | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2023-03-10 | 183 | 0 |
| K213513 | Vented Vial Adapter 20mm | West Pharma. Services IL, Ltd. | 2022-08-31 | 302 | 0 |
| K212525 | Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devic | Advcare Medical | 2022-08-19 | 373 | 0 |
| K220856 | Vial Adapter Ø13mm | Avenir Performance Européenne Medical (Apem) | 2022-06-21 | 90 | 0 |
| K212445 | freeflex+ Transfer Adapter | Fresenius Kabi AG | 2022-06-01 | 300 | 0 |
| K212530 | IVX Fluid Transfer Set | Omnicell, Inc. | 2022-04-24 | 256 | 1 |
| K202732 | SOL-CARE IV Bag Safety Connector | Sol-Millennium Medical Group | 2021-11-03 | 411 | 0 |
| K203674 | B Dispensing Line | Aea Srl | 2021-09-27 | 285 | 0 |
| K200893 | ProntoPump Sterile Tube Set | Ipax, Inc. | 2021-05-04 | 396 | 0 |
| K201469 | Mini Spike Plus 6/8R | B.Braun Medical, Inc. | 2020-12-09 | 189 | 0 |
| K201415 | Vial2Bag Advanced 20mm Admixture Device | West Pharmaceutical Services Az, Inc. | 2020-10-21 | 145 | 1 |
| K192154 | Rio Vial-to-Bag Drug Reconstitution Device | Icu Medical | 2020-04-20 | 255 | 0 |
| K182819 | Decanting Device | Gcmedica Enterprise Ltd.(Wuxi) | 2019-12-02 | 424 | 0 |
| K190816 | Vial Adapter Ø20 mm , Vial Adapter Ø13 mm | Avenir Performance Europeenne Medical (Apem) | 2019-11-19 | 235 | 0 |
| K190149 | Vial Adapter Ø20 mm | Avenir Performance Europeenne Medical (Apem) | 2019-10-15 | 259 | 0 |
| K183187 | nextaro Transfer System, nextaro va | Sfm Medical Devices GmbH | 2019-03-15 | 116 | 0 |
| K173577 | Guarded Luer Connector | International Medical Industries, Inc. | 2018-06-07 | 199 | 1 |
| K162216 | GRI-FILL PERISTALTIC SET | Laboratorios Grifols, S.A. | 2017-10-19 | 437 | 0 |
| K171796 | Vial Adapter 15mm | Medimop Medical Project , Ltd. | 2017-10-12 | 118 | 0 |
| K172884 | Arisure Closed Vial Adapter | Yukon Medical | 2017-10-03 | 12 | 0 |
| K172631 | Arisure Dry Spike | Yukon Medical | 2017-09-29 | 28 | 0 |
| K170095 | Vial2Bag Direct Connect | Medimop Medical Project , Ltd. | 2017-03-08 | 56 | 2 |
| K161800 | OnSite-IV | Pharmc, LLC | 2016-12-06 | 159 | 0 |
| K160503 | Vented Vial Adapter Transfer Device - 13mm | Medimop Medical Projects, Ltd. | 2016-05-04 | 70 | 0 |
| K151423 | APEX Compounding System Transfer Set | B.Braun Medical, Inc. | 2016-02-19 | 267 | 0 |
| K152441 | KIRO Set | Kiro Robotics S.L. | 2015-12-04 | 99 | 0 |
| K150787 | Universal Spike | B.Braun Medical, Inc. | 2015-12-02 | 252 | 0 |
| K151963 | SmartSite Vented Vial Access Device | Yukon Medical, LLC | 2015-07-31 | 15 | 0 |
| K142600 | VIAL-MATE Adaptor | Baxter Healthcare Corporation | 2014-11-19 | 65 | 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