FDA product code KFJ: Materials, Repair Or Replacement, Pacemaker
KFJ is the FDA product code for materials, repair or replacement, pacemaker. It is a Class III device, regulated under 21 CFR 870.3710 and reviewed by the Cardiovascular panel. FDA has cleared 3 510(k) submissions under KFJ, from 3 different applicants. The average 510(k) review took 65 days (median 50).
Classification
| Field | Value |
|---|---|
| Device name | Materials, Repair Or Replacement, Pacemaker |
| Device class | Class III |
| Regulation | 21 CFR 870.3710 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | PMA |
| Implant | Yes |
Compare with all 510(k) review times · Search every KFJ clearance
Top KFJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Telectronics Pacing Systems, Inc. | 1 | 1991-12-31 |
| Medtronic Vascular | 1 | 1985-07-11 |
| Intermedics, Inc. | 1 | 1982-01-12 |
Most recent KFJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K913919 | Telectronics Pacing Systems, Inc. | UNIVERSAL TERMINAL CAP, 3.2MM | 1991-12-31 | 119 |
| K852236 | Medtronic Vascular | MEDTRONIC MODEL 5867-1A | 1985-07-11 | 50 |
| K813518 | Intermedics, Inc. | IMPLANT AID SPLICING CRIMP & SLEEVE | 1982-01-12 | 27 |
Recalls for KFJ devices
openFDA lists no recalls for product code KFJ.
Frequently asked questions
What is FDA product code KFJ?
KFJ is the FDA product code for materials, repair or replacement, pacemaker. It is a Class III device, regulated under 21 CFR 870.3710 and reviewed by the Cardiovascular panel.
What device class is KFJ?
Class III, regulation 21 CFR 870.3710. Typical premarket route: PMA.
How long does a 510(k) take for product code KFJ?
Across 3 cleared submissions the average was 65 days from receipt to decision (median 50).
Which companies have the most KFJ clearances?
Telectronics Pacing Systems, Inc. (1); Medtronic Vascular (1); Intermedics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KFJ
- Run a recall and safety report across every KFJ manufacturer
- Watch product code KFJ 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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