Metron Qa-Ids I.V. Pump Tester

Q: What is the product code of K982020?

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

FDA 510(k) K982020 · Metron U.S., Inc.

Substantially Equivalent

510(k) numberK982020

Submission

Device name: Metron Qa-Ids I.V. Pump Tester
Applicant: Metron U.S., Inc.
Crofton, MD, US
Received: June 9, 1998
Decision date: September 30, 1998
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement 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
K973991	Metron QA-510 SPO2 AnalyzerDQA · Traditional	01/16/1998SE
K963190	QA-40M Defibrillator TesterDRL · Traditional	07/01/1997SE
K963198	PS-41 6M Patient SimulatorDPS · Traditional	03/05/1997SE

Questions and answers

When was Metron Qa-Ids I.V. Pump Tester cleared by the FDA?

Metron Qa-Ids I.V. Pump Tester (K982020) received a 510(k) decision of Substantially Equivalent on September 30, 1998, 113 days after the submission was received.

What is the product code of K982020?

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