Product Code: FLB FDA class 2 21 CFR 876.5820

Meter, Conductivity, Induction, Remote Type

Gastroenterology, Urology

The Remote-Type Induction Conductivity Meter is an instrument that uses inductive sensing to measure the electrical conductivity of dialysate solutions, allowing verification of proper dialysate concentration during hemodialysis. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FLB, regulated under 21 CFR 876.5820 in the Gastroenterology and Urology specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

Registration Numbers

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Basic Information

Product Code: FLB
Device Class: FDA class 2
Regulation Number: 876.5820
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 6 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K100237	DIALYSATE METER, MODEL D-6	Apr 23, 2010	Substantially Equivalent	Myron L Company
K925210	90DX MULTITEST METER, MODIFICATION	Jan 25, 1994	Substantially Equivalent	Mesa Medical, Inc.
K882032	MODEL 90DX MULTITEST METER	Aug 11, 1988	Substantially Equivalent	Mesa Medical, Inc.
K830629	COBE RX METER	Apr 06, 1983	Substantially Equivalent	Cobe Laboratories, Inc.
K821415	MODEL 90 BC	May 27, 1982	Substantially Equivalent	Western Laboratories Corp.
K770263	DIALYSATE METER RS-2100A, CIRCUIT CHANGE	Feb 18, 1977	Substantially Equivalent	Renal Systems, Inc.