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Saratoga SCT Heated Humidification System

by Saratoga Medical Instrumentation, Inc.

510(k) K854363

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 NumberK854363 Date31 Dec 1985ClearedStatusActive

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  • Withdrawn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
BTT
Device Class
Class II
Regulation
21 CFR Part 868.5450
Advisory Committee
Anesthesiology
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 Saratoga SCT Heated Humidification System is a respiratory gas humidifier with direct patient interface, classified under device class 2 and product code BTT. It is designed to condition respiratory gases by adding heat and moisture for delivery to patients.

This device is supplied as a reusable system and has received FDA 510(k) clearance under number K854363, with a substantially equivalent decision dated December 31, 1985. It is intended for use in anesthesiology settings and complies with regulation number 868.5450.

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 Saratoga SCT Heated Humidification System used for?

    The Saratoga SCT Heated Humidification System is designed to condition respiratory gases by adding heat and moisture for delivery to patients, specifically intended for use in anesthesiology settings to maintain appropriate humidity and temperature levels during respiratory support.

  • Is the Saratoga SCT Heated Humidification System reusable or single-use?

    The device is supplied as a reusable system, meaning it is designed for multiple uses after appropriate cleaning and reprocessing between patients, as indicated in the device description which specifies it is a reusable system.

  • What regulatory clearance does the Saratoga SCT Heated Humidification System have?

    The Saratoga SCT Heated Humidification System has received FDA 510(k) clearance under number K854363, with a substantially equivalent decision dated December 31, 1985, based on the traditional clearance pathway for device class 2 under product code BTT.