COSYTHERM - NCB1

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

510(k) Number

K061902 ↗

FDA Product Code

DWJ

Models / Variants

NCM1

NCM2

NCB1

CCU1

CRU1

Device Class

Class II

Regulation

21 CFR Part 870.5900

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Inditherm Patient Warming System, Models MECU1; OTM1; OTM2; GTM1; PTM1; Otb; RB1

  Class II

  FDA 510(k) K051419 Active Cleared 27 Apr 2006

• What clinical settings is the CosyTherm designed to support, and how does it help in those environments?

  The CosyTherm is specifically designed for neonatal and pediatric patients to maintain or regulate body temperature in critical care, transport, or post-delivery scenarios. It provides controlled heating to prevent hypothermia in vulnerable infants, ensuring thermal stability in settings like neonatal intensive care units (NICU), special care baby units (SCBU), delivery suites, and postnatal wards. Its precise temperature regulation helps mitigate risks associated with temperature instability in these high-risk environments.

• Is the CosyTherm a single-use or reusable device, and what does this mean for maintenance and cleaning?

  The CosyTherm is a reusable system, intended for use in clinical settings where precise temperature management is required. As a reusable device, it must be properly cleaned, disinfected, and maintained between uses to ensure safety and functionality. The manufacturer’s instructions should be followed to avoid cross-contamination and preserve performance.

• What models of the CosyTherm are available, and how do they differ from one another?

  The CosyTherm comes in five models: NCM1, NCM2, NCB1, CCU1, and CRU1. While the exact differences between these models are not detailed in the provided data, each is tailored for specific applications within neonatal and pediatric thermal regulation. The models likely vary in design, functionality, or intended use cases (e.g., transport vs. stationary use), but all adhere to the same core purpose of maintaining body temperature in vulnerable patients.

• How was the CosyTherm approved by the FDA, and what does this mean for its regulatory status?

  The CosyTherm received FDA clearance through a 510(k) submission (K061902) under the Traditional clearance type, determined to be Substantially Equivalent (SESE) to a predicate device. This means the FDA found it to be as safe and effective as a previously approved thermal regulating system for neonatal and pediatric patients. The clearance was granted under 21 CFR 870.5900, which pertains to cardiovascular and thermal regulation devices, and was reviewed by the Cardiovascular (CV) Advisory Committee. No third-party review or sterility requirements were noted in the submission.

• Does the CosyTherm require any special storage conditions, and what should clinicians consider when storing it?

  The provided data does not specify storage conditions for the CosyTherm, but as a reusable medical device, it should be stored in a clean, dry environment to prevent contamination or damage. Clinicians should follow the manufacturer’s guidelines for maintenance, calibration, and storage to ensure optimal performance and compliance with clinical protocols. Proper handling is particularly important for devices used in neonatal care, where reliability is critical.