Oxygen Enrichment Kit, Models SG 066, SG 067

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K992670 ↗

FDA Product Code

CBK

Device Class

Class II

Regulation

21 CFR Part 868.5895

Advisory Committee

Anesthesiology

FDA Decision

ST

• Non-Rebreathing 't' (Be 117)

  Class II

  FDA 510(k) K973066 Active Cleared 3 Feb 1998

• Be 410 Endotracheal Tube/Trach Tube, Pilot Repair

  Class II

  FDA 510(k) K884638 Active Cleared 23 Nov 1988

• Sg-066 Oxygen Enrichment Kit

  Class II

  FDA 510(k) K860077 Active Cleared 18 Feb 1986

• Gas Collhctor Be 155(155-2-3, 154-4)

  Class I

  FDA 510(k) K770632 Active Cleared 8 Apr 1977

• Ms-303-Oxygen Regulator Shield

  Class I

  FDA 510(k) K810679 Active Cleared 17 Apr 1981

• Flex Arm Be 122, Clamp 122-27

  Class I

  FDA 510(k) K770631 Active Cleared 23 May 1977

See all devices from Instrumentation Industries, Inc. →

• What is the Oxygen Enrichment Kit used for?

  The Oxygen Enrichment Kit is designed for use on certain ventilators to mix room air with a supplemental oxygen source at the proximal airway, thereby increasing the oxygen concentration delivered to the patient. It functions as an accessory to ventilators and facilitates oxygen delivery to patients requiring respiratory support, improving oxygenation levels in clinical settings.

• How is the Oxygen Enrichment Kit supplied and what models are available?

  The device is supplied as Models SG 066 and SG 067. It is intended for facility use by healthcare professionals in clinical settings. The provided data does not specify whether it is sterile, single-use, reusable, or MRI-safe.

• What regulatory pathway was used for the Oxygen Enrichment Kit?

  The Oxygen Enrichment Kit received FDA 510(k) clearance under K992670 and is classified as a Class II device under regulation number 868.5895 with product code CBK. The clearance type is Traditional, and it was found substantially equivalent subject to tracking requirements.