Skip to content

Opti- System

by Corpak Co.

510(k) K810559

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 NumberK810559 Date17 Mar 1981ClearedStatusActive

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  • Withdrawn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, 23 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 Opti-System is a respiratory gas humidifier designed as a direct patient interface. It functions to provide humidified gas to patients during respiratory therapy.

This device is classified as a Class 2 medical device under the anesthesiology specialty. It has received FDA 510(k) clearance under the traditional pathway.

Other devices from Corpak Co.

See all devices from Corpak Co. →

Questions

AI-generated answers, 23 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 primary function of the Opti-System?

    The Opti-System is a respiratory gas humidifier designed to serve as a direct patient interface. Its purpose is to provide humidified gas to patients undergoing respiratory therapy.

  • How is this device classified for regulatory purposes?

    The Opti-System is classified as a Class 2 medical device under the anesthesiology specialty. It has received FDA 510(k) clearance through the traditional pathway.

  • Which medical specialty is associated with this device?

    This device is categorized under the anesthesiology specialty, as indicated by its regulatory filing and product code classification.