Adidyne 3000

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K771707 ↗

FDA Product Code

BTI

Device Class

Class II

Regulation

21 CFR Part 868.6250

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Meck/Miller Ventilation Tube Harness

  Class I

  FDA 510(k) K760993 Active Cleared 9 Dec 1976

• MO8 Oxygen Flowmeter

  Class I

  FDA 510(k) K802311 Active Cleared 23 Oct 1980

• Criterion I

  Class II

  FDA 510(k) K834274 Active Cleared 13 Apr 1984

• Rt-200 Calibration Analyzer

  Class I

  FDA 510(k) K822746 Active Cleared 13 Oct 1982

• Regulator, Oxygen Mechanical

  Class I

  FDA 510(k) K803207 Active Cleared 15 Jan 1981

• Datascribe #ds-40

  Class I

  FDA 510(k) K812765 Active Cleared 16 Nov 1981

See all devices from Timeter Instrument Corp. →

• What is the Adidyne 3000 used for in medical settings?

  The Adidyne 3000 is a portable air compressor designed specifically for anesthesiology applications. It provides pressurized air to support respiratory functions, ensuring consistent airflow for ventilation systems during surgical procedures or patient care.

• Is the Adidyne 3000 a single-use or reusable device?

  The Adidyne 3000 is a reusable medical instrument. Like other reusable devices, it requires proper maintenance, cleaning, and sterilization between uses to ensure safety and functionality, following the manufacturer’s guidelines.

• What regulatory pathway does the Adidyne 3000 follow?

  The Adidyne 3000 is classified as a Class II medical device under FDA regulations and has obtained 510(k) clearance (K771707) through a traditional review pathway. This means it has been evaluated for substantial equivalence to a predicate device already on the market.

• Can the Adidyne 3000 be used in MRI environments?

  No, the Adidyne 3000 is explicitly not indicated for use in MRI environments. Its design and materials are not compatible with magnetic resonance imaging settings, so it should only be used in non-MRI areas.

• What maintenance and storage requirements does the Adidyne 3000 have?

  The Adidyne 3000 requires regular maintenance and proper storage as outlined by the manufacturer to ensure optimal performance and longevity. This includes routine inspections, cleaning, and adherence to guidelines for handling a reusable medical device in clinical settings.