510(k) K243486
- Device
- SmartSiteTM Vented Vial Access Device
- Applicant
- Yukon Medical, LLC
- 510(k) number
- K243486
- Product code
- LHI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-12-06
- Date received
- 2024-11-08
- Regulation
- 880.5440
- Classification name
- Set, I.V. Fluid Transfer
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Y
Related Records
Applicant Contact
- Contact
- Todd Korogi
- Address
- 4021 Stirrup Creek Dr. Suite 200 Durham NC US 27703 27703
FDA Registration Numbers
- 1423662
- 1450662
- 2521402
- 3038356900
- 3013820501
- 1423507
- 8021083
- 1416980
- 2650143
- 1061124
- 3011392709
- 1720734
- 3020706315
- 3013234390
- 3015531959
- 3017406698
- 3016418550
- 9614854
- 3010291427
- 1037885
- 3042177665
- 3013188547
- 9615908
- 1000150646
- 1035907
- 3020417125
- 2032098
- 1018470
- 3012429465
- 1019003
- 2649614
- 3006946348
- 3030447506
- 3015176617
- 1420088
- 2016945
- 3001124136
- 3013557562
- 8031007
- 1319660
- 3007880912
- 3003704957
- 1000163068
- 3015488952
- 3012307300
- 3003678543
- 3013298431
- 3003152976
- 3017636737
- 2024024
- 9612052
- 3009340644
- 3004194523
- 3009756327
- 9681819
- 3003674698
- 3008810357
- 3005245797
- 3000279201
- 3018125942
- 3030626857
- 1835568
- 9614279
- 3002907620
- 3013319212
- 3004201393
- 3009631669
- 1058584
- 3004548776
- 2953359
- 1530671
- 3013561817
- 3027645738
- 1713468
- 3003768277
- 3013445787
- 3000223297
- 1526863
- 3014579161
Source Documents
Other 510(k) Records For Product Code LHI
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250345 | Medline Bag Decanter | Medline Industries, LP | 2025-10-24 |
| K251715 | FlowArt® Vial Access Device Vented | Asset Medikal | 2025-10-14 |
| K251676 | Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S) | Microtek Medical, LLC | 2025-09-16 |
| K243404 | HyHub and HyHub Duo Vial Access Devices | Takeda Pharmaceuticals | 2025-07-18 |
| K240761 | Arisure® Closed Male Luer with Spike Adapter (YM060) | Yukon Medical, LLC | 2025-03-21 |
| K243985 | Rio Drug Reconstitution Transfer Device | Icu Medical, Inc. | 2025-01-22 |
| K241976 | nextaro® va, 15mm, 5µm | Sfm Medical Devices GmbH | 2024-09-06 |
| K233287 | Vent Vial Adapter | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2024-07-26 |
| K232987 | FlowArt Valve for Vial Access | Asset Medikal Tasarim Sanayi VE Ticaret A.S. | 2024-06-26 |
| K240940 | Vial2Bag Advanced® 20mm Admixture Device | West Pharmaceutical Services, Inc. | 2024-05-03 |
| K233284 | Vial Adapter with Filter | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2024-05-01 |
| K240748 | nextaro® v, 20/20 | Sfm Medical Devices GmbH | 2024-04-16 |
| K233021 | BD SmartSite 13mm Vial Access Device; BD SmartSite 20mm Vial Access Device | Care Fusion | 2024-03-06 |
| K231071 | Mix2Vial® Transfer Device | West Pharma. Services IL, Ltd. | 2024-01-19 |
| K232875 | Vial Adapter 20mm | West Pharma. Services IL, Ltd. | 2023-12-14 |