Spectrum and Spectrum with Master Drug Library

Q: What is the product code of K042121?

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

FDA 510(k) K042121 · Sigma Intl.

Substantially Equivalent

510(k) numberK042121

Submission

Device name: Spectrum and Spectrum with Master Drug Library
Applicant: Sigma Intl.
Medina, NY, US
Received: August 6, 2004
Decision date: August 26, 2004
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA
Third-party review: Yes

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

510(k)	Device	Applicant	Decision
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
K962709	Sigma Syringe Delivery System(Multi-Doser Rev. 1/MULTI-DOSER Rev. Ii/Single-Doser Rev.…FRN · Traditional	10/07/1996SE
K942162	Sigma 8000 and Sigma 8002FRN · Traditional	10/20/1994SE

Questions and answers

When was Spectrum and Spectrum with Master Drug Library cleared by the FDA?

Spectrum and Spectrum with Master Drug Library (K042121) received a 510(k) decision of Substantially Equivalent on August 26, 2004, 20 days after the submission was received.

What is the product code of K042121?

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