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Omega Cares System

by J-F Medical Systems Intl., Inc.

510(k) K945068

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 NumberK945068 Date25 Jan 1996ClearedStatusActive

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  • Withdrawn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
DQK
Device Class
Class II
Regulation
21 CFR Part 870.1425
Advisory Committee
Cardiovascular
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.

The Omega Cares System is a cardiovascular device manufactured by J-F Medical Systems Intl., Inc. It is designed for use in cardiovascular procedures and applications.

The device is supplied as a system and is intended for single-use. It has received FDA 510(k) clearance with product code DQK and is available in various sizes. The device should be stored according to the manufacturer's instructions and is not MRI compatible.

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 clinical applications is the Omega Cares System intended for?

    The Omega Cares System is designed for use in cardiovascular procedures, providing clinicians with a ready‑to‑use solution for interventions such as catheter‑based therapies. Its single‑use configuration helps maintain sterility and performance throughout the procedure.

  • How is the Omega Cares System supplied and what sizes are available?

    The system is supplied as a complete, single‑use kit that includes all necessary components for a cardiovascular case. It is offered in a range of sizes to accommodate different patient anatomies and procedural requirements, allowing clinicians to select the most appropriate configuration for each case.

  • What are the storage and handling requirements for this device?

    The Omega Cares System must be stored according to the manufacturer’s instructions, which typically involve keeping the unopened kit in a controlled environment protected from extreme temperatures and moisture. Proper storage preserves the device’s sterility and functional integrity until the point of use.

  • Is the Omega Cares System compatible with MRI environments?

    No, the device is not MRI compatible. Because it contains materials that could be affected by magnetic fields, it should not be brought into the MRI suite. Clinicians should plan alternative imaging strategies when MRI is required.

  • What regulatory pathway did the Omega Cares System follow?

    The system received FDA 510(k) clearance under a traditional review, demonstrating substantial equivalence to a predicate device with product code DQK. This clearance indicates that the device meets the safety and effectiveness standards required for market entry in the United States.