FDA product code LKD: Monitor, Carbon-Dioxide, Cutaneous
LKD is the FDA product code for monitor, carbon-dioxide, cutaneous. It is a Class II device, regulated under 21 CFR 868.2480 and reviewed by the Anesthesiology panel. FDA has cleared 17 510(k) submissions under LKD, 1 in the last five years, from 14 different applicants. The average 510(k) review took 207 days (median 170); 273 days on average over the last three years. 8 PMA applications cite this product code. FDA has posted 23 recalls for LKD devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Monitor, Carbon-Dioxide, Cutaneous |
| Device class | Class II |
| Regulation | 21 CFR 868.2480 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
510(k) clearances per year for LKD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 273 |
Compare with all 510(k) review times · Search every LKD clearance
Top LKD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sentec AG | 3 | 2024-05-17 |
| Radiometer Medical Aps | 2 | 2010-02-05 |
| Perimed AB | 1 | 2013-10-22 |
| Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 1 | 2011-09-30 |
| Linde Medical Sensors AG | 1 | 2005-03-04 |
9 more applicants have LKD clearances. See the full list in Caduvo.
Most recent LKD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K232516 | Sentec AG | Sentec Digital Monitoring System (SDMS) tCOM+ | 2024-05-17 | 273 |
| K151329 | Sentec AG | SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet | 2015-12-17 | 213 |
| K131253 | Perimed AB | PERIFLUX 6000 | 2013-10-22 | 173 |
| K110474 | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | PHILIPS INTELLIVUE TCG10 | 2011-09-30 | 224 |
| K101690 | Sentec AG | SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE | 2010-12-03 | 170 |
Recalls for LKD devices
23 product recalls in 15 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2023-07-25.
| Year | Recalls |
|---|---|
| 2019 | 5 |
| 2020 | 2 |
| 2022 | 1 |
| 2023 | 2 |
Frequently asked questions
What is FDA product code LKD?
LKD is the FDA product code for monitor, carbon-dioxide, cutaneous. It is a Class II device, regulated under 21 CFR 868.2480 and reviewed by the Anesthesiology panel.
What device class is LKD?
Class II, regulation 21 CFR 868.2480. Typical premarket route: 510(k).
How long does a 510(k) take for product code LKD?
Across 17 cleared submissions the average was 207 days from receipt to decision (median 170).
Which companies have the most LKD clearances?
Sentec AG (3); Radiometer Medical Aps (2); Perimed AB (1); Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (1); Linde Medical Sensors AG (1).
Have LKD devices been recalled?
Yes: 23 product recalls across 15 recall events; the most recent began 2023-07-25.
Next steps
- Run an FDA pathway report with predicate devices for product code LKD
- Run a recall and safety report across every LKD manufacturer
- Watch product code LKD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Anesthesiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times