Stilith Cardiac Pacemakers-M 60 & 120

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

510(k) Number

K780781 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Pacing Lead Models MAM 1260 MAM 1290

  Class III

  FDA 510(k) K781621 Active Cleared 8 Dec 1978

• Pacing Lead Model Bus 860, Bus 890

  Class III

  FDA 510(k) K781624 Active Cleared 21 Dec 1978

• Pacing Lead Adapter, Acv 14, Acv 23

  Class II

  FDA 510(k) K781626 Active Cleared 8 Dec 1978

• Pacing Lead Models MDM 1060, MDM 1090

  Class III

  FDA 510(k) K781620 Active Cleared 8 Dec 1978

• Pacing Lead Model MVM 860, MVM 890

  Class III

  FDA 510(k) K781625 Active Cleared 8 Dec 1978

• Pacing Models Mum 860, Mum 890

  Class III

  FDA 510(k) K781623 Active Cleared 8 Dec 1978

See all devices from R.E. Brown Co., Inc. →

• What is the primary purpose of the Stilith Cardiac Pacemakers-M. 60 & 120, and who would benefit from using it?

  The Stilith Cardiac Pacemakers-M. 60 & 120 are designed to regulate abnormal heart rhythms by delivering electrical impulses to the heart muscle. They are intended for patients with bradycardia or conduction disorders requiring consistent cardiac pacing to maintain proper heart function. This makes them suitable for individuals whose natural heart rate is too slow or irregular, ensuring stable cardiac output.

• Are these pacemakers intended for single-use or reusable applications, and what does that mean for surgical planning?

  The Stilith Cardiac Pacemakers-M. 60 & 120 are explicitly labeled for single-use implantation. This means each device is sterile upon packaging and should not be reused after one surgical procedure. Clinicians must adhere to sterile handling protocols before implantation, as reuse could compromise patient safety and device efficacy.

• How should these pacemakers be stored prior to use, and what precautions should be taken?

  Since the Stilith Cardiac Pacemakers-M. 60 & 120 are supplied sterile, they must be stored in their original packaging until immediately before implantation. The packaging should remain unopened and protected from contamination, moisture, or physical damage. Proper storage ensures sterility is maintained, which is critical for preventing post-operative infections or complications.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for clinicians?

  The Stilith Cardiac Pacemakers-M. 60 & 120 received FDA 510(k) clearance (K780781) under the Cardiovascular advisory committee, classified as a Class III device (Implantable Pacemaker Pulse-Generator). This means the device was deemed substantially equivalent to a legally marketed predicate, ensuring it meets established safety and performance standards. Clinicians can rely on this clearance as evidence of regulatory scrutiny, though they should always follow manufacturer instructions and local protocols for implantation.