Vari-Set

FDA 510(k) K894111 · Sonex Medical

Substantially Equivalent

510(k) numberK894111

Submission

Device name
Vari-Set
Applicant
Sonex Medical
Salt Lake City, UT, US
Received
June 12, 1989
Decision date
September 28, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LDR – Controller, Infusion, Intravascular, Electronic
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5725
Specialty
General Hospital

Other 510(k)s with product code LDR

510(k)DeviceApplicantDecision
K242693DEKA Infusion System, DEKA Administration SetLDR · Special Deka Research and Development Corporation10/07/2024SE
K232316DEKA Infusion System, DEKA Administration SetLDR · Traditional Deka Research and Development03/01/2024SE
K153760Volumetric Infusion ControllerLDR · Traditional DEKA Research & Development10/03/2016SE
K963136Pacer Model 100 Infusion ControllerLDR · Traditional Health Watch, Inc.10/10/1997SE
K971865Alexander Manufacturing Co. Rechargeable Battery Part Number M12/500-3PLDR · Traditional Alexander Mfg. Co.07/03/1997SE
K971826Alexander Manufacturing Co. Rechargeable Battery Part Number M12/500LDR · Traditional Alexander Mfg. Co.07/03/1997SE
K934543Universal Controller, Model 100LDR · Traditional Metamed, Inc.03/29/1994SE
K935236Flow Controlling Extension SetLDR · Traditional Block Medical, Inc.02/24/1994SE
K905498Stat 2 IV PumpetteLDR · Traditional The Master Medical Corp.04/16/1991SE
K905497Master Flow I.V. PumpetteLDR · Traditional The Master Medical Corp.04/16/1991SE

Questions and answers

When was Vari-Set cleared by the FDA?

Vari-Set (K894111) received a 510(k) decision of Substantially Equivalent on September 28, 1989, 108 days after the submission was received.

What is the product code of K894111?

The FDA product code is LDR – Controller, Infusion, Intravascular, Electronic, a Class II (moderate risk) device regulated under 21 CFR 880.5725.