Exacta-Mix 2400 Compounding System, Model Exacta-Mix 2400
FDA 510(k) K002705 · Baxa Corp.
510(k) numberK002705
Submission
- Device name
- Exacta-Mix 2400 Compounding System, Model Exacta-Mix 2400
- Applicant
- Baxa Corp.
Englewood, CO, US - Received
- August 30, 2000
- Decision date
- March 28, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LHI – Set, I.V. Fluid Transfer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
Other 510(k)s with product code LHI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252987 | ADRx Admixture DeviceLHI · Traditional | Epic Medical Pte. , Ltd. | 06/12/2026SE |
| K260301 | Vial AdapterLHI · Traditional | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 06/05/2026SE |
| K250345 | Medline Bag DecanterLHI · Traditional | Medline Industries, LP | 10/24/2025SE |
| K251715 | FlowArt® Vial Access Device VentedLHI · Traditional | Asset Medikal | 10/14/2025SE |
| K251676 | Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II…LHI · Traditional | Microtek Medical, LLC | 09/16/2025SE |
| K243404 | HyHub and HyHub Duo Vial Access DevicesLHI · Traditional | Takeda Pharmaceuticals | 07/18/2025SE |
| K240761 | Arisure® Closed Male Luer with Spike Adapter (YM060)LHI · Traditional | Yukon Medical, LLC | 03/21/2025SE |
| K243985 | Rio Drug Reconstitution Transfer DeviceLHI · Traditional | Icu Medical, Inc. | 01/22/2025SE |
| K243486 | SmartSiteTM Vented Vial Access DeviceLHI · Traditional | Yukon Medical, LLC | 12/06/2024SE |
| K241976 | nextaro® va, 15mm, 5µmLHI · Special | Sfm Medical Devices GmbH | 09/06/2024SE |
More from Sfm Medical Devices GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K090917 | Sureconnect Closed Drug Reconstitution and Transfer SystemLHI · Traditional | 02/19/2010SE |
| K070163 | Swabbable Cap, Model 60205ODI · Traditional | 08/03/2007SE |
| K062909 | Repeater Pump II Tube SetsFPA · Traditional | 03/09/2007SE |
| K022523 | Rapid-Fill Tubeset, Model 90005LHI · Traditional | 08/12/2002SE |
| K983321 | Microfuse Dual Rate InfuserFRN · Special | 10/06/1998SE |
| K951871 | Piston SyringeFMF · Traditional | 06/21/1995SE |
| K933506 | Syringe InfuserFRN · Traditional | 02/25/1994SE |
Questions and answers
When was Exacta-Mix 2400 Compounding System, Model Exacta-Mix 2400 cleared by the FDA?
Exacta-Mix 2400 Compounding System, Model Exacta-Mix 2400 (K002705) received a 510(k) decision of Substantially Equivalent on March 28, 2001, 210 days after the submission was received.
What is the product code of K002705?
The FDA product code is LHI – Set, I.V. Fluid Transfer, a Class II (moderate risk) device regulated under 21 CFR 880.5440.