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Castle Series 100HC Steam Sterilizers

by Getinge/Castle, Inc.

510(k) K994314

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK994314 Date16 Feb 2000ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FLE
Device Class
Class II
Regulation
21 CFR Part 880.6880
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Castle Series 100HC Steam Sterilizers are devices intended for use by healthcare facilities to sterilize wrapped and unwrapped surgical instruments, linens, and liquids (not intended for direct patient contact) by means of pressurized steam. These devices are classified as steam sterilizers and are designed for general hospital use.

The Castle Series 100HC Steam Sterilizers are supplied as reusable devices and are not specified as single-use. The device is FDA 510(k) cleared with K994314, classified under product code FLE, and regulation number 880.6880. The device received FDA clearance on February 16, 2000, as substantially equivalent.

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Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Castle Series 100HC Steam Sterilizer used for?

    The Castle Series 100HC Steam Sterilizer is intended for use by healthcare facilities to sterilize wrapped and unwrapped surgical instruments, linens, and liquids that are not intended for direct patient contact, using pressurized steam as the sterilizing agent.

  • Is the Castle Series 100HC Steam Sterilizer a single-use or reusable device?

    The Castle Series 100HC Steam Sterilizer is supplied as a reusable device and is not specified as single-use, meaning it is designed for multiple sterilization cycles after proper cleaning and maintenance between uses.

  • What types of items can be sterilized in the Castle Series 100HC Steam Sterilizer?

    This device can sterilize wrapped and unwrapped surgical instruments, linens, and liquids, provided they are not intended for direct patient contact, making it suitable for general hospital use where such items require steam-based sterilization.

  • What regulatory pathway was used for the Castle Series 100HC Steam Sterilizer?

    The Castle Series 100HC Steam Sterilizer received FDA 510(k) clearance under K994314 on February 16, 2000, as substantially equivalent to a legally marketed predicate device, and is classified under product code FLE and regulation number 880.6880.