Patient Cables and Leadwires , Disposable ECG Leadwires

Q: What is the product code of K182327?

The FDA product code is DSA – Cable, Transducer And Electrode, Patient, (Including Connector), a Class II (moderate risk) device regulated under 21 CFR 870.2900.

FDA 510(k) K182327 · Orantech, Inc.

Substantially Equivalent

510(k) numberK182327

Submission

Device name: Patient Cables and Leadwires , Disposable ECG Leadwires
Applicant: Orantech, Inc.
Shenzhen, CN
Received: August 27, 2018
Decision date: January 30, 2019
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: DSA – Cable, Transducer And Electrode, Patient, (Including Connector)
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.2900
Specialty: Cardiovascular

Other 510(k)s with product code DSA

510(k)	Device	Applicant	Decision
K254114	Baylis Connector CableDSA · Special	Baylis Medical Technologies, Inc.	01/18/2026SE
K252827	IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott…DSA · Traditional	Drägerwerk AG & Co. KGaA	12/01/2025SE
K251669	IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger…DSA · Traditional	Shanghai Draeger Medical Instrument Co., Ltd.	09/30/2025SE
K242986	SpO2 Extension CableDSA · Special	Beijing Rongrui-Century Science & Technology…	05/02/2025SE
K243545	Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171…DSA · Traditional	Philips Medizin Systeme Böblingen GmbH	01/17/2025SE
K240087	RT Carbon ECG LeadsDSA · Traditional	Ivy Biomedical Systems, Inc.	09/13/2024SE
K240377	LIFEPAK® ECG CablesDSA · Traditional	Stryker Physio-Control	05/07/2024SE
K240156	LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV…DSA · Traditional	Physio-Control, Inc.	04/30/2024SE
K222712	Fogg System Patient Monitoring CablesDSA · Traditional	Fogg System Company, Inc.	11/22/2023SE
K230571	RFP-100A Connector Cable (Single Use)DSA · Traditional	Baylis Medical Technologies, Inc.	05/30/2023SE

More from Baylis Medical Technologies, Inc.

510(k)	Device	Decision
K173194	Temperature ProbeFLL · Traditional	10/10/2018SE
K181270	Disposable SpO2 Sensors, Reusable SpO2 SensorsDQA · Traditional	09/07/2018SE
K173197	Reusable NIBP CuffDXQ · Traditional	08/21/2018SE
K171828	ETCO2 SensorCCK · Traditional	05/31/2018SE

Questions and answers

When was Patient Cables and Leadwires , Disposable ECG Leadwires cleared by the FDA?

Patient Cables and Leadwires , Disposable ECG Leadwires (K182327) received a 510(k) decision of Substantially Equivalent on January 30, 2019, 156 days after the submission was received.

What is the product code of K182327?

The FDA product code is DSA – Cable, Transducer And Electrode, Patient, (Including Connector), a Class II (moderate risk) device regulated under 21 CFR 870.2900.