# LKD: Monitor, Carbon-Dioxide, Cutaneous

- Device class: 2; regulation: 21 CFR 868.2480; FDA's rule: 510(k) required
- FDA decisions: 17
- 510(k) review time 2021–2025: median 273 days (middle half 273–273)
- Recalls: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1997: 1
- 1998: 2
- 1999: 1
- 2004: 1
- 2005: 2
- 2010: 2
- 2011: 1
- 2013: 1
- 2015: 1
- 2024: 1

## Most-cited predicates
- K110474: Philips Intellivue TCG10 (2011), cited by 8
- K101690: Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor Adaper Cable (2010), cited by 3
- K041548: Sentec Digital Monitor Model #SDM (2004), cited by 2
- K093154: TCM Tosca Monitoring System, TCM Combim Monitoring System (2010), cited by 2
- K043003: TCM40 Monitoring System (2005), cited by 2
- K900333: E5280 Combined Transcutaneous TCP02/TCPCO2 Elect. (1990), cited by 2
- K891481: Siemens Sirecust Transcutaneous Carbon Dioxide (1989), cited by 1
- K043357: Tosca 500 PCO2, SPO2 and Pulse Rate Monitoring System, Model 5202009 (2005), cited by 1
- K151329: SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet (2015), cited by 1

Source page: https://510kreport.com/product-code/LKD
Data by year (CSV): https://510kreport.com/product-code/LKD.csv