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Sechrist IV-100B SAVI System

by Sechrist

510(k) K920121

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK920121 Date1 Feb 1993ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1032-04 FDA Unclassified (pre-2012) initiated 20 May 2004

    Electronic manometer malfunctions. Manometer may be illegible. The alarm for power failure may function only briefly, or not at all.

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  • Withdrawn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
CBK
Device Class
Class II
Regulation
21 CFR Part 868.5895
Advisory Committee
Anesthesiology
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.

The Sechrist IV-100B SAVI System is a continuous ventilator designed for facility use, classified as a Class II medical device. It is intended for use in anesthesiology settings and provides ventilatory support for infant and pediatric patients.

The device is supplied as a reusable system and operates under microprocessor control with easy-to-use interface for monitoring and adjusting ventilation parameters. It received FDA 510(k) clearance (K920121) on February 1, 1993, as substantially equivalent to a predicate device, and is authorized for distribution in the United States.

Other devices from Sechrist

Questions

AI-generated answers, 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.

  • What is the Sechrist IV-100B SAVI System intended for?

    The Sechrist IV-100B SAVI System is intended for use in anesthesiology settings to provide ventilatory support for infant and pediatric patients. It is a continuous ventilator designed for facility use, as stated in the device description, and is not intended for any other clinical application beyond what is specified in its labeling.

  • Is the Sechrist IV-100B SAVI System reusable or single-use?

    The device is supplied as a reusable system, meaning it is designed for multiple uses after appropriate cleaning, disinfection, and maintenance procedures. This is explicitly stated in the description, which notes that it operates under microprocessor control and is intended for repeated facility use rather than single-patient disposal.

  • How was the Sechrist IV-100B SAVI System cleared for marketing in the United States?

    The Sechrist IV-100B SAVI System received FDA 510(k) clearance (K920121) on February 1, 1993, as substantially equivalent to a predicate device. This traditional 510(k) pathway was used to demonstrate its safety and effectiveness for the intended use in anesthesiology for infant and pediatric ventilatory support.

  • What regulatory classification does the Sechrist IV-100B SAVI System have?

    The device is classified as a Class II medical device, as indicated in the description and confirmed by the FDA product code CBK and regulation number 868.5895. This classification reflects its risk level and the regulatory controls required for its marketing and use in the United States.

  • What type of facility is the Sechrist IV-100B SAVI System designed for?

    The Sechrist IV-100B SAVI System is designed for facility use, specifically in anesthesiology settings such as hospitals or surgical centers where ventilatory support for infant and pediatric patients is required. It is not intended for transport, home use, or emergency medical services outside of a controlled clinical facility.