Patient Ventilator Isolator

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K880923 ↗

FDA Product Code

CBK

Device Class

Class II

Regulation

21 CFR Part 868.5895

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Bag-Tail Bleed Valve

  Class I

  FDA 510(k) K870859 Active Cleared 3 Aug 1987

• Universal Tourniquet

  Class I

  FDA 510(k) K873928 Active Cleared 23 Oct 1987

• Dryden Scavenger Interface System

  Not classified

  FDA 510(k) K842843 Active Cleared 27 Jul 1984

• Breathing Circuit W/Heated Wire

  Class II

  FDA 510(k) K880769 Active Cleared 24 Aug 1988

• Nasopharyngeal Airway-Robertazzi

  Class I

  FDA 510(k) K850644 Active Cleared 21 Mar 1985

• Reuseable Non-Conductive Fixed Y

  Class I

  FDA 510(k) K841455 Active Cleared 11 Jun 1984

See all devices from Dryden Corp. →

• What is the PATIENT VENTILATOR ISOLATOR intended for?

  The PATIENT VENTILATOR ISOLATOR is intended for use in anesthesiology to isolate a patient from a ventilator circuit, as stated in the device description, and is designed for facility use in clinical settings where ventilator support is required.

• Who manufactures the PATIENT VENTILATOR ISOLATOR and where is it authorized for use?

  The PATIENT VENTILATOR ISOLATOR is manufactured by Dryden Corp. and is authorized for use in the United States under FDA regulation 868.5895, based on the traditional 510(k) clearance K880923 granted on September 6, 1988.

• What regulatory pathway was used for the PATIENT VENTILATOR ISOLATOR and what is its classification?

  The PATIENT VENTILATOR ISOLATOR received traditional 510(k) clearance (K880923) and is classified as a Class II medical device, as indicated by the device_class=2 in the openfda field and the decision_code SESE showing substantial equivalence to a predicate.