Multilith Pulse Generators 1141 & 2141

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

510(k) Number

K842193 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Pacing Lead #PMA F 860

  Class III

  FDA 510(k) K830457 Active Cleared 17 Mar 1983

• Opus Pulse Generators Models 2001, 2003, and 2004

  Class III

  FDA 510(k) K882474 Active Cleared 12 Sep 1988

• Lead Models MUM 1260, MUM 1290

  Class III

  FDA 510(k) K790386 Active Cleared 3 Apr 1979

• Focus J81F, J83F, J41F, J43F Pacing Leads

  Class III

  FDA 510(k) K896742 Active Cleared 17 Jul 1990

• Focus T41, T41F, T43, T43F, T44F

  Class III

  FDA 510(k) K904255 Active Cleared 18 Jan 1991

• Opus Pacemakers (Models 4001, 4003, 4004, 4023, 4024)

  Class III

  FDA 510(k) K952364 Active Cleared 1 Sep 1995

See all devices from Ela Medical, Inc. →

• Are the Multilith Pulse Generators 1141 & 2141 intended for single-use or can they be reused after implantation?

  The Multilith Pulse Generators 1141 & 2141 are designed as reusable devices, meaning they are intended to remain implanted in the patient long-term and are not meant for single-use. They are supplied sterile and are classified as implantable pacemaker pulse-generators, which are typically intended for permanent cardiac rhythm regulation.

• What regulatory pathway was followed for FDA clearance of these pulse generators, and what does that mean for their use in clinical settings?

  The Multilith Pulse Generators 1141 & 2141 received FDA 510(k) clearance under the classification K842193, with a decision of Substantially Equivalent (SESE). This means the FDA determined they are as safe and effective as a legally marketed device that served as a predicate, ensuring compliance with stringent safety and performance standards for Class III implantable pacemaker systems. Their regulatory category (870.3610) and advisory committee review (Cardiovascular) confirm their high-risk, life-sustaining classification.

• How are the Multilith Pulse Generators 1141 & 2141 supplied, and what should clinicians consider regarding sterility and handling?

  The devices are supplied as sterile, reusable pulse generators, meaning they are pre-sterilized for implantation and intended to remain implanted in the patient. Clinicians should follow manufacturer guidelines for aseptic handling during implantation to maintain sterility, as these are high-risk, implantable devices requiring careful preparation to prevent infection or contamination.

• What types of cardiac conditions are these pulse generators intended to address, and how do they function?

  The Multilith Pulse Generators 1141 & 2141 are designed to regulate cardiac rhythm by delivering electrical impulses to the heart, specifically for patients requiring cardiac pacing support. They are not intended for any specific diagnosis but rather for patients with conditions causing abnormal heart rhythms (e.g., bradycardia) where pacing is clinically indicated. Their function aligns with standard implantable pacemaker systems to maintain proper heart rate and rhythm.