Unimed Disposable ECG lead wires
FDA 510(k) K142489 · Unimed Medical Supplies, Inc.
510(k) numberK142489
Submission
- Device name
- Unimed Disposable ECG lead wires
- Applicant
- Unimed Medical Supplies, Inc.
Shenzhen, CN - Received
- September 4, 2014
- Decision date
- November 4, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K253162 | Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes…FLL · Traditional | 06/05/2026SE |
| K260931 | Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)DQA · Special | 04/14/2026SE |
| K253964 | Disposable Neonatal NIBP Cuff (U1681S-C51N)DXQ · Special | 01/09/2026SE |
| K251696 | Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2…DQA · Traditional | 12/01/2025SE |
| K251691 | Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08…DQA · Traditional | 12/01/2025SE |
| K251695 | Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06…DQA · Traditional | 11/18/2025SE |
| K251693 | Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75…DQA · Traditional | 11/18/2025SE |
| K250931 | Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2…DQA · Traditional | 08/13/2025SE |
| K251045 | Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff…DXQ · Traditional | 07/15/2025SE |
| K243086 | Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed Reusable…DQA · Traditional | 02/20/2025SE |
Questions and answers
When was Unimed Disposable ECG lead wires cleared by the FDA?
Unimed Disposable ECG lead wires (K142489) received a 510(k) decision of Substantially Equivalent on November 4, 2014, 61 days after the submission was received.
What is the product code of K142489?
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.