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Steam Sterilizers B 28 Series

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K151597

by CEFLA s.c.

Identifiers

510(k) Number
K151597 FDA 510(k)
FDA Product Code
FLE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.6880 FDA 510(k)
Regulation Number
880.6880 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Steam Sterilizers B 28 Series are medical devices designed for steam sterilization of reusable medical and surgical instruments, devices, and supplies. These sterilizers utilize high-temperature steam to eliminate microorganisms, ensuring a sterile environment for healthcare procedures in clinical settings.

These sterilizers are intended for use in general hospital environments and are supplied as reusable equipment. They comply with FDA 510(k) clearance (K151597) and EU MDR regulations, with multiple model-specific FEI numbers listed for identification. Sterilization cycles are conducted in controlled conditions, and the devices are classified as Class II medical devices under FDA regulations.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Family of Steam Sterilizers B 28 series (K151597) — FDA 510 (k ..., PDF K151597 - Family of Steam Sterilizers B 28 series, Family Of Steam Sterilizers B 28 Series 510(k) K151597 - fda.report, Family of Steam Sterilizers B 28 series (K151597) — FDA 510 (k ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
CEFLA s.c.

Sources (2)

  • FDA 510(k) K151597 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026