Alaris PC Unit, Models 8000 and 8015

Q: What is the product code of K091308?

The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.

FDA 510(k) K091308 · Cardinal Health 303,Inc.

Substantially Equivalent

510(k) numberK091308

Submission

Device name: Alaris PC Unit, Models 8000 and 8015
Applicant: Cardinal Health 303,Inc.
San Diego, CA, US
Received: May 4, 2009
Decision date: July 9, 2009
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: FRN – Pump, Infusion
Device class: Class II (moderate risk)
Regulation: 21 CFR 880.5725
Specialty: General Hospital

Other 510(k)s with product code FRN

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K253703	RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionFRN · Traditional	Deka R&D Corp	07/24/2026SE
K252015	FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingFRN · Traditional	Koru Medical Systems, Inc.	01/28/2026SE
K251640	SIGMA Spectrum Infusion Pump with Master Drug LibraryFRN · Traditional	Baxter Healthcare Corporation	07/28/2025SE
K251636	Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)FRN · Traditional	Baxter Healthcare Corporation	07/28/2025SE
K242752	MRidium 3870 MRI Infusion Pump System (3870)FRN · Traditional	Iradimed Corporation	05/28/2025SE
K243855	BD Alaris Infusion System with Guardrails Suite MXFRN · Traditional	Carefusion 303, Inc.	04/25/2025SE
K242115	Plum Duo Precision IV PumpFRN · Traditional	Icu Medical, Inc.	04/02/2025SE
K242114	Plum Solo Precision IV PumpFRN · Traditional	Icu Medical, Inc.	04/02/2025SE
K250357	RemunityPRO Pump for Remodulin® (treprostinil) InjectionFRN · Special	Deka Research & Development Corp.	03/11/2025SE
K241736	Remunity 2.0 Pump for Remodulin (treprostinil) InjectionFRN · Traditional	Deka Research and Development Corp.	01/16/2025SE

More from Deka Research and Development Corp.

510(k)	Device	Decision
K072105	Alaris System with MMS, Model 8XXXFRN · Special	12/28/2007SE
K070268	Signature Edition Infusion System, Models 710X, 720XFRN · Special	02/23/2007SE
K063288	Signature Edition Gold Infusion System, Model 7X3XFRN · Special	11/28/2006SE

Questions and answers

When was Alaris PC Unit, Models 8000 and 8015 cleared by the FDA?

Alaris PC Unit, Models 8000 and 8015 (K091308) received a 510(k) decision of Substantially Equivalent on July 9, 2009, 66 days after the submission was received.

What is the product code of K091308?

The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.