Sonacolor 6100

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K801647 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K874684 Active Cleared 25 Apr 1988

• Vascumap Medical Air Plethysmograph

  Class II

  FDA 510(k) K914200 Active Cleared 7 Nov 1991

• Sonacolor Cd, Model 6300 Cardiac Doppler Ultrasound

  Not classified

  FDA 510(k) K837329 Active Cleared 7 Jun 1983

• Dopscan Plus DS1060

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  FDA 510(k) K843891 Active Cleared 9 Jan 1985

• Patient Heater System, Model PH112

  Class II

  FDA 510(k) K772015 Active Cleared 15 Nov 1977

• Probe, Uptake, Nuclear

  Class I

  FDA 510(k) K864624 Active Cleared 10 Aug 1987

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• What is the primary purpose of the Sonacolor 6100 pacemaker, and who would benefit from using it?

  The Sonacolor 6100 is an implantable pacemaker pulse-generator designed to regulate cardiac rhythm by delivering electrical impulses to the heart. It is intended for patients with bradycardia or conduction disorders who require artificial pacing to maintain a stable heart rate. This device is specifically for those whose natural cardiac electrical system is insufficient to sustain proper heart function.

• Is the Sonacolor 6100 meant for single-use or can it be reused after implantation?

  The Sonacolor 6100 is supplied as a single-use implantable unit. Once implanted, it is intended to remain in place as a permanent solution for the patient’s pacing needs. Reuse is not recommended or supported by the manufacturer’s specifications.

• How should the Sonacolor 6100 be handled during surgical implantation to ensure sterility?

  The Sonacolor 6100 is intended for sterile surgical implantation and must be handled using aseptic techniques. This means the device should be opened and used in a controlled, sterile environment to prevent contamination, as it is not designed for non-sterile procedures.

• What regulatory pathway was followed for the approval of the Sonacolor 6100, and what classification does it hold?

  The Sonacolor 6100 was cleared through the FDA’s 510(k) pathway under the classification of a Class III medical device (regulation number 870.3610). It was determined to be substantially equivalent to a predicate device, and the clearance number assigned is K801647. This classification reflects its role as an implantable cardiac device requiring rigorous regulatory oversight.

• Are there different models or sizes available for the Sonacolor 6100, and if so, how would a clinician determine the appropriate one for a patient?

  The provided data does not specify distinct models or sizes for the Sonacolor 6100, but it is listed under multiple registration numbers, which may correspond to variations or batches. Clinicians would typically rely on manufacturer guidelines, patient-specific measurements, and clinical assessment to determine compatibility and proper use, though specific sizing details are not outlined in the available information.