Ohio Disposable Clear Suction Instrument

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K801641 ↗

FDA Product Code

DTS

Device Class

Class II

Regulation

21 CFR Part 870.4420

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Ohio Absorber

  Class I

  FDA 510(k) K821144 Active Cleared 28 May 1982

• Ohio Disposable Tracheal Tube

  Class II

  FDA 510(k) K810763 Active Cleared 27 Mar 1981

• Ohio Cpu-1 Intensive Care Ventilator

  Class II

  FDA 510(k) K822888 Active Cleared 16 Nov 1982

• Ohio 7000 Electronic Anesthesia Ventil.

  Class II

  FDA 510(k) K821376 Active Cleared 29 Jun 1982

• Ohio Free Flow Vacuum Regulator

  Class II

  FDA 510(k) K801169 Active Cleared 28 Jul 1980

• Non-Reusable Universal Nebulizer Filter

  Class II

  FDA 510(k) K823257 Active Cleared 9 Dec 1982

See all devices from Airco/Ohio Medical Products →

• What clinical procedures is the Ohio Disposable Clear Suction Instrument intended for?

  The instrument is designed for use during cardiovascular surgeries, specifically for suctioning blood and fluids in cardiotomy return and cardiopulmonary bypass applications. Its disposable, clear design helps maintain a clean field and reduces the risk of cross‑contamination during these high‑risk procedures.

• Is the device supplied sterile and for single‑use only?

  Yes, the instrument is provided sterile and is intended for a single patient use only. This eliminates the need for re‑processing, ensures consistent performance, and supports infection control protocols in the operating room.

• How is the Ohio Disposable Clear Suction Instrument regulated?

  The device received FDA 510(k) clearance (K801641) and is classified as a Class 2 cardiovascular device under product code DTS. This clearance indicates it is substantially equivalent to a legally marketed predicate device and meets the applicable safety and effectiveness standards.

• What are the storage requirements for this suction instrument?

  Because it is supplied sterile, the instrument should be stored in its original packaging in a clean, dry environment until the point of use. Maintaining the packaging integrity protects sterility and ensures the device functions as intended when opened in the operating suite.

• Are there multiple sizes or models available for this suction instrument?

  The provided data does not list alternative sizes or model variations; it describes a single disposable clear suction instrument. If additional sizes are needed, users should contact Ohio Medical Products for possible product extensions or accessories.