Valve Controller for Micromacro Compounder

Q: What is the product code of K903159?

The FDA product code is LHI – Set, I.V. Fluid Transfer, a Class II (moderate risk) device regulated under 21 CFR 880.5440.

FDA 510(k) K903159 · Baxa Corp., Sub. of Cook Group, Inc.

Substantially Equivalent

510(k) numberK903159

Submission

Device name: Valve Controller for Micromacro Compounder
Applicant: Baxa Corp., Sub. of Cook Group, Inc.
Englewood, CO, US
Received: July 18, 1990
Decision date: November 7, 1990
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

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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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
K910257	Baxa Pca InfusorMEA · Traditional	11/07/1991SE
K904225	KwikmixLHI · Traditional	11/05/1990SE
K900585	Tubing Sets for Baxa Exacta-Med Pharmacy PumpLHI · Traditional	04/18/1990SE
K873875	Baxa Exacta-Med Pharmacy PumpFRN · Traditional	11/24/1987SE
K872743	Baxa Tubing Sets (for Pharmacy Pump)FMF · Traditional	10/09/1987SE
K844904	Cytosafe NeedleLHI · Traditional	02/22/1985SE
K832347	Twofer NeedleLHI · Traditional	09/12/1983SE
K832332	Vented I.V. Transfer NeedleLHI · Traditional	09/12/1983SE
K832312	I.V. Transfer NeedleLHI · Traditional	09/12/1983SE
K832254	Baxa AddisealKPE · Traditional	07/26/1983SE

Questions and answers

When was Valve Controller for Micromacro Compounder cleared by the FDA?

Valve Controller for Micromacro Compounder (K903159) received a 510(k) decision of Substantially Equivalent on November 7, 1990, 112 days after the submission was received.

What is the product code of K903159?

The FDA product code is LHI – Set, I.V. Fluid Transfer, a Class II (moderate risk) device regulated under 21 CFR 880.5440.