Home › Device types › LKD
Monitor, Carbon-Dioxide, Cutaneous
FDA product code LKD · Class 2 · Anesthesiology
120
Registered devices
78
Adverse events
23
Recalls
17
510(k) clearances
Devices with this code
TC pO2/pCO2 Membraning kit For TC electrode — Radiometer Medical ApSExtension cable For TCM3 electrodes, 3m — Radiometer Medical ApSTC 550 Fixation Ring for tcpO2/CO2 — Perimed ABPatient Application Kit with Ear Clip for mature/intact skin — SenTec AGPSG Cable B — SenTec AGPSG Cable C — SenTec AGMulti-Site Attachment Ring for mature/intact skin — SenTec AGEar Clip easy — SenTec AGtc Sensor 54 — Radiometer Medical ApSTCM4x Cable — Radiometer Medical ApSTC 555 Fixation Ring for tcpO2/CO2 - Extra Strength Adhesive — Perimed ABElectrolyte 54 — Radiometer Medical ApSMembrane Changer (reloadable) / single unit — SenTec AGContact Gel — SenTec AGElectrolyte 84 — Radiometer Medical ApSTOSCA Open end interface cable 5V FS — Radiometer Basel AGTC electrode — Radiometer Medical ApSSpirometry Sensor — Philips Medizin Systeme Böblingen GmbHFixation Kit For TC electrodes — Radiometer Medical ApSTOSCA 500 Cable — Radiometer Basel AGCalibration Gas — Radiometer Medical ApSTOSCA Open end nurse call cable — Radiometer Basel AGSenTec Digital Monitor (with activated PO2 channel) — SenTec AGTCM 4 series ETX base unit — Radiometer Medical ApS
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-07-25 | SenTec AG | During rework of components during the manufacturing process, an additional piece of material may have been left in the device, which may result in an impact on |
| 2023-05-02 | SenTec AG | The sensors may experience an out-of-box failure because after recalibration, the sensors stayed in the software mode "production" and were not reset to "releas |
| 2022-08-22 | SenTec AG | Weak skin adhesion. |
| 2020-12-10 | SenTec AG | Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards. |
| 2020-02-20 | Radiometer Medical ApS | Reports have been received about the transcutaneous monitoring system display flickering or monitor becoming non responsive and beeping. This may result in dela |
| 2019-05-02 | SenTec AG | There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure. |
| 2019-05-02 | SenTec AG | There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure. |
| 2019-05-02 | SenTec AG | There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure. |
| 2019-05-02 | SenTec AG | There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure. |
| 2019-05-02 | SenTec AG | There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure. |
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