Temperature Probe-TP150

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K952800 ↗

FDA Product Code

FMT

Device Class

Class II

Regulation

21 CFR Part 880.5130

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Temperature Probe-TP450

  Class II

  FDA 510(k) K952804 Active Cleared 4 Apr 1996

• Quantum Edge Pediatric Defirbrillation Electrodes

  Class III

  FDA 510(k) K970391 Active Cleared 6 Mar 1997

• Temperature Probe-TP550

  Class II

  FDA 510(k) K952805 Active Cleared 4 Apr 1996

• Noah Monitoring Electrode System

  Class II

  FDA 510(k) K970125 Active Cleared 4 Mar 1997

• Temperature PROBE-TP650

  Class II

  FDA 510(k) K952807 Active Cleared 4 Apr 1996

• Disposable Hydrogel Defibrillation Electrode/Pad

  Class III

  FDA 510(k) K960329 Active Cleared 2 Jul 1996

See all devices from Contour Medical Technology, Inc. →

• What clinical setting is the Temperature Probe TP150 designed for, and how does it integrate with existing equipment?

  The TP150 is specifically designed for use with infant radiant warmers in neonatal care settings, particularly within general hospital environments. It measures and displays temperature readings to help maintain precise thermal regulation for infants. Since it is a disposable probe, it is intended to be used once per patient and then discarded, ensuring sterility and reducing cross-contamination risks. The probe connects directly to compatible radiant warmers, allowing clinicians to monitor and adjust temperature settings accurately during neonatal care.

• Is the Temperature Probe TP150 reusable, or is it intended for single-use only? How does this affect its handling and storage?

  The TP150 is explicitly designed as a single-use, disposable device, meaning it is intended for one-time use per patient. This design ensures sterility and minimizes infection risks in clinical environments. As a result, proper handling and storage must follow standard sterile medical device protocols—typically in sealed, sterile packaging until use, and then immediate disposal after use to avoid contamination.

• What regulatory pathway was followed for the FDA clearance of the Temperature Probe TP150, and what does this mean for its use in hospitals?

  The TP150 received FDA 510(k) clearance (K952800) under the Traditional 510(k) pathway, with a decision classification of Substantially Equivalent to a predicate device. This means the FDA determined it has the same intended use and technological characteristics as a previously cleared device, ensuring it meets safety and effectiveness standards for use in general hospital settings. Hospitals can rely on this clearance to confirm the probe’s compliance with U.S. regulatory requirements for neonatal temperature monitoring.

• How is the Temperature Probe TP150 supplied, and what should clinicians consider when ordering or stocking it?

  The TP150 is supplied as a disposable, sterile probe in individual packaging, ready for immediate clinical use. Since it is single-use, clinicians should order it in bulk quantities based on anticipated patient volume to ensure availability without waste. Storage should follow standard sterile medical device protocols—protected from moisture, extreme temperatures, and physical damage—to maintain its integrity until use. Always verify expiration dates and packaging integrity before use.