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Saniclave 250

by Revolutionary Science

510(k) K180272

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 · Traditional NumberK180272 Date26 Jul 2018ClearedStatusActive

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  • Withdrawn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, 27 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 Saniclave 250 is a steam sterilizer device classified as a General Hospital device under regulation number 880.6880. It is substantially equivalent to a predicate device and received traditional 510(k) clearance from the FDA under K180272.

The device is manufactured by Revolutionary Science and supplied as a non-sterile, reusable unit intended for use in general hospital settings. It is designed to sterilize standard medical instruments and hormone pelleting trocars, with no claims regarding sterility, single-use status, MRI safety, or storage conditions provided in the data.

Questions

AI-generated answers, 27 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 Saniclave 250 used for?

    The Saniclave 250 is designed to sterilize standard medical instruments and hormone pelleting trocars in general hospital settings, as indicated by its classification under regulation number 880.6880 and its substantial equivalence to a predicate device.

  • Is the Saniclave 250 supplied sterile or non-sterile, and is it single-use or reusable?

    The Saniclave 250 is supplied as a non-sterile, reusable unit, meaning it is not provided in a sterile condition and is intended for multiple uses after proper reprocessing, based on the device description.

  • What regulatory pathway was used for the Saniclave 250, and what is its K-number?

    The Saniclave 250 received traditional 510(k) clearance from the FDA under K180272, indicating it was found substantially equivalent to a legally marketed predicate device through the traditional review process.