Patient Monitoring Cables for ECG, EKG, SPO2 and Blood Pressure Monitors
FDA 510(k) K082959 · Unimed Medical Supplies, Inc.
510(k) numberK082959
Submission
- Device name
- Patient Monitoring Cables for ECG, EKG, SPO2 and Blood Pressure Monitors
- Applicant
- Unimed Medical Supplies, Inc.
Shenzhen, Guangdong, CN - Received
- October 3, 2008
- Decision date
- October 10, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 Patient Monitoring Cables for ECG, EKG, SPO2 and Blood Pressure Monitors cleared by the FDA?
Patient Monitoring Cables for ECG, EKG, SPO2 and Blood Pressure Monitors (K082959) received a 510(k) decision of Substantially Equivalent on October 10, 2008, 7 days after the submission was received.
What is the product code of K082959?
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.