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OXYCON

by Home Medical Mfg., Co., Inc.

510(k) K813436

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 NumberK813436 Date7 Jan 1982ClearedStatusActive

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  • Withdrawn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
CAW
Device Class
Class II
Regulation
21 CFR Part 868.5440
Advisory Committee
Anesthesiology
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.

OXYCON is a portable oxygen generator device classified under product code CAW and regulation number 868.5440. It is a substantially equivalent device cleared through the FDA 510(k) process under traditional review, with decision date January 7, 1982, and K-number K813436.

The device is manufactured by Home Medical Mfg., Co., Inc. in McHenry, Illinois, and is authorized for distribution in the United States. It falls under the medical specialty of anesthesiology and is registered with multiple facility identifier numbers as listed in the openFDA data. No claims about sterility, single-use status, MRI safety, sizes, storage, or clinical indications are made in the provided 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 OXYCON device used for?

    The OXYCON is a portable oxygen generator classified under product code CAW and regulation number 868.5440, intended for use in the medical specialty of anesthesiology as indicated by its FDA 510(k) clearance and device classification.

  • How was the OXYCON device authorized for distribution?

    The OXYCON device was cleared through the FDA 510(k) process under traditional review as a substantially equivalent device, with decision date January 7, 1982, and K-number K813436, authorizing its distribution in the United States.

  • Who manufactures the OXYCON device and where is it made?

    The OXYCON device is manufactured by Home Medical Mfg., Co., Inc. in McHenry, Illinois, United States, as specified in the device data including facility address and registration details.