Pharmulator
FDA 510(k) K896990 · Acacia, Inc.
510(k) numberK896990
Submission
- Device name
- Pharmulator
- Applicant
- Acacia, Inc.
Loma Linda, CA, US - Received
- December 13, 1989
- Decision date
- March 23, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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
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|---|---|---|---|
| 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 |
|---|---|---|
| K142527 | Extension Set with BD Q-Syte Luer Access Split SeptumFPA · Traditional | 09/19/2014SE |
| K122449 | Enteral Nutrition WarmerLGZ · Traditional | 06/13/2013SE |
| K111381 | Medi-Sis Syringe Infusion SystemLZH · Traditional | 01/13/2012SE |
| K103165 | Blood Sampling SetFPA · Traditional | 11/10/2010SE |
| K092986 | Acacia Piston SyringeFMF · Traditional | 10/27/2009SE |
| K972538 | Flow-Eze Blunt Cannula (1999BC)FMI · Traditional | 07/15/1998SE |
| K931095 | Spring Loaded SyringeFMF · Traditional | 09/16/1993SE |
| K912771 | Acacias Pharm/PumpLHI · Traditional | 02/14/1992SE |
| K901063 | Luer Lock Transfer PinLHI · Traditional | 07/06/1990SE |
| K894206 | IntopoFMF · Traditional | 10/27/1989SE |
Questions and answers
When was Pharmulator cleared by the FDA?
Pharmulator (K896990) received a 510(k) decision of Substantially Equivalent on March 23, 1990, 100 days after the submission was received.
What is the product code of K896990?
The FDA product code is LHI – Set, I.V. Fluid Transfer, a Class II (moderate risk) device regulated under 21 CFR 880.5440.