Cverne Cad Detector

Q: What is the product code of K852900?

The FDA product code is DXG – Computer, Diagnostic, Pre-Programmed, Single-Function, a Class II (moderate risk) device regulated under 21 CFR 870.1435.

FDA 510(k) K852900 · Cherne Industries, Inc.

Substantially Equivalent

510(k) numberK852900

Submission

Device name: Cverne Cad Detector
Applicant: Cherne Industries, Inc.
Minneapolis, MN, US
Received: July 9, 1985
Decision date: September 25, 1985
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: DXG – Computer, Diagnostic, Pre-Programmed, Single-Function
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.1435
Specialty: Cardiovascular

Other 510(k)s with product code DXG

510(k)	Device	Applicant	Decision
K253092	Argos Infinity (Rev. 1.0)DXG · Traditional	Retia Medical Systems, Inc.	02/13/2026SE
K251275	VitalStream ART Connect; VitalStream-HemoDXG · Traditional	Caretaker Medical	09/26/2025SE
K232048	Cogent Hemodynamic Monitoring System; Cogent HMSDXG · Traditional	Icu Medical	12/20/2023SE
K212529	Hypotension Decision Assist Model HDA-OR2DXG · Special	Directed Systems, Ltd.	11/23/2021SE
K192169	PulsioFlex Monitoring System with ProAQT SensorDXG · Traditional	Pulsion Medical Systems SE	04/30/2020SE
K193179	EV1000 Clinical PlatformDXG · Special	Edwards Lifesciences, LLC	12/17/2019SE
K190955	Hypotension Decision AssistDXG · Traditional	Directed Systems, Ltd.	11/27/2019SE
K181372	ArgosDXG · Traditional	Retia Medical, LLC	12/13/2018SE
K172259	PulsioFlex Monitoring SystemDXG · Traditional	Pulsion Medical Systems SE	01/18/2018SE
K163334	LiDCOunity v2 Hemodynamic MonitorDXG · Traditional	Lidco, Ltd.	06/05/2017SE

More from Lidco, Ltd.

510(k)	Device	Decision
K864072	Adec 1005-C ChairLGX · Traditional	11/07/1986SE
K860015	Modified Cherne Cad DetectorDXG · Traditional	04/23/1986SE

Questions and answers

When was Cverne Cad Detector cleared by the FDA?

Cverne Cad Detector (K852900) received a 510(k) decision of Substantially Equivalent on September 25, 1985, 78 days after the submission was received.

What is the product code of K852900?

The FDA product code is DXG – Computer, Diagnostic, Pre-Programmed, Single-Function, a Class II (moderate risk) device regulated under 21 CFR 870.1435.