FDA product code NKE: Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

NKE is the FDA product code for pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p). It is a Class III device, reviewed by the Cardiovascular panel. Devices under NKE reach the market by PMA; FDA lists no cleared 510(k)s for it. 6 PMA applications cite this product code. FDA has posted 28 recalls for NKE devices, 8 initiated in the last five years.

Definition

These devices are indicated for patients who have moderate to severe heart failure. These new devices use an additional lead to provide synchronized pacing of the heart, in addition to the regular features of a pacemaker. These products are sought for the treatment of patients who have moderate to severe heart failure.

Classification

Recalls for NKE devices

28 product recalls in 12 recall events; 8 initiated in the last five years and 18 still open. Most recent: 2026-03-19.

HCPCS codes with matching descriptors

Text match between the FDA device name and CMS descriptors, not an official crosswalk:

• C7540 — Removal of permanent pacemaker pulse generator with replacement of pacemaker pulse generator, dual lead system, with insertion of pacing electrode, cardiac venous system, for left ventricular pacing, at time of insertion of implantable defibrillator or pacemaker pulse generator (eg, for upgrade to dual chamber system)
• C7538 — Insertion of new or replacement of permanent pacemaker with ventricular transvenous electrode(s), with insertion of pacing electrode, cardiac venous system, for left ventricular pacing, at time of insertion of implantable defibrillator or pacemaker pulse generator (e.g., for upgrade to dual chamber system)
• C7539 — Insertion of new or replacement of permanent pacemaker with atrial and ventricular transvenous electrode(s), with insertion of pacing electrode, cardiac venous system, for left ventricular pacing, at time of insertion of implantable defibrillator or pacemaker pulse generator (eg, for upgrade to dual chamber system)
• C7537 — Insertion of new or replacement of permanent pacemaker with atrial transvenous electrode(s), with insertion of pacing electrode, cardiac venous system, for left ventricular pacing, at time of insertion of implantable defibrillator or pacemaker pulse generator (e.g., for upgrade to dual chamber system)
• C1767 — Generator, neurostimulator (implantable), non-rechargeable

Frequently asked questions

What is FDA product code NKE?

NKE is the FDA product code for pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p). It is a Class III device, reviewed by the Cardiovascular panel.

What device class is NKE?

Class III. Typical premarket route: PMA.

Have NKE devices been recalled?

Yes: 28 product recalls across 12 recall events; the most recent began 2026-03-19.

Next steps

• Run an FDA pathway report with predicate devices for product code NKE
• Run a recall and safety report across every NKE manufacturer
• Watch product code NKE for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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