Lifespan(Tm) Model 4110 TCPO2/CO2 Monitoring Syste

No FDA recalls found in the data synced 22 Oct 2026.

Trade Name

Lifespan(Tm) 100 TCPCO2 Monitor

Generic Name

MONITOR, CARBON-DIOXIDE, CUTANEOUS

PMA Number

P820019 ↗

510(k) Number

K812643 ↗

FDA Product Code

CCK

Device Class

Class II

Regulation

21 CFR Part 868.1400

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

PMA Supplement

S007

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• What clinical scenarios is the Lifespan Model 4110 primarily used for, and why is transcutaneous monitoring preferred in these settings?

  The Lifespan Model 4110 is designed for real-time, non-invasive transcutaneous monitoring of carbon dioxide (CO₂) and oxygen (TcPO₂) levels, making it ideal for patients in anesthesia or critical care where continuous physiological assessment is critical. Transcutaneous monitoring avoids the risks and discomfort of invasive blood sampling while providing immediate data to evaluate respiratory function and metabolic status, which is essential during procedures or in unstable patients.

• Is the Lifespan Model 4110 reusable, and if so, what does that mean for maintenance and cleaning requirements?

  Yes, the Lifespan Model 4110 is supplied as a reusable medical device. This means it must be properly cleaned, disinfected, and maintained between uses to ensure accuracy, hygiene, and longevity. Hospitals should follow manufacturer guidelines for cleaning protocols to prevent cross-contamination and preserve the device’s performance for continuous monitoring in clinical settings.

• What regulatory pathways does the Lifespan Model 4110 follow, and how does that affect its use in hospitals?

  The device follows both **FDA Premarket Approval (PMA P820019)** and **510(k) clearance (K812643)**, confirming it meets Class II regulatory standards for non-invasive transcutaneous monitoring. This ensures compliance with strict safety and performance requirements, giving hospitals confidence in its reliability for critical care and anesthesia applications while adhering to U.S. medical device regulations.

• Are there different models or configurations available for the Lifespan Model 4110, and how might that impact selection for a hospital?

  The data lists multiple **FEI numbers (e.g., 3002807167, 3013500228)**, which may correspond to different model variants or accessories for the Lifespan 4110 system. While exact specifications aren’t detailed, these variations could include sensor types, software updates, or additional monitoring features. Hospitals should verify compatibility with their workflows and patient needs before purchasing, as some configurations may better suit anesthesia suites or ICU environments.

• How should the Lifespan Model 4110 be stored, and are there any special considerations for its environment?

  Since the device is reusable and not specified as sterile, it should be stored in a clean, dry environment protected from extreme temperatures, moisture, or physical damage. Proper calibration and maintenance checks should be performed regularly as part of storage protocols to ensure accuracy. Hospitals should also follow manufacturer recommendations to avoid exposure to electromagnetic interference or incompatible electrical systems, which could affect its performance in clinical settings.