Sigma 8000 and Sigma 8002

Q: What is the product code of K942162?

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

FDA 510(k) K942162 · Sigma Intl.

Substantially Equivalent

510(k) numberK942162

Submission

Device name: Sigma 8000 and Sigma 8002
Applicant: Sigma Intl.
Medina, NY, US
Received: May 4, 1994
Decision date: October 20, 1994
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

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
K042121	Spectrum and Spectrum with Master Drug LibraryFRN · Traditional	08/26/2004SE
K962709	Sigma Syringe Delivery System(Multi-Doser Rev. 1/MULTI-DOSER Rev. Ii/Single-Doser Rev.…FRN · Traditional	10/07/1996SE

Questions and answers

When was Sigma 8000 and Sigma 8002 cleared by the FDA?

Sigma 8000 and Sigma 8002 (K942162) received a 510(k) decision of Substantially Equivalent on October 20, 1994, 169 days after the submission was received.

What is the product code of K942162?

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