Steam Autoclave Control. & Datalog. by Datacon

by Pharmetics, Inc.

510(k) K874644

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

510(k) K874644↗

FDA record

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

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK874644	Date27 Jan 1988Cleared	StatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K874644
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, 19 Sep 2026

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

This device is a Steam Sterilizer (Autoclave) designed to sterilize medical products using pressurized steam. It combines control functionality with data logging capabilities to monitor and record sterilization cycles, ensuring compliance with sterilization protocols and maintaining documentation of process parameters.

The Steam Autoclave Control and Datalog is intended for use in healthcare settings, such as general hospitals, and is classified as a Class II device under FDA regulations. It operates as a reusable medical device, requiring proper maintenance and calibration. The device holds an FDA 510(k) clearance (K874644) and adheres to regulatory standards outlined in 21 CFR 880.6880. No third-party reprocessing is indicated, and its use is governed by established sterilization protocols.