FDA product code KRG: Programmer, Pacemaker
KRG is the FDA product code for programmer, pacemaker. It is a Class III device, regulated under 21 CFR 870.3700 and reviewed by the Cardiovascular panel. FDA has cleared 25 510(k) submissions under KRG, from 11 different applicants. The average 510(k) review took 132 days (median 77). 8 PMA applications cite this product code. FDA has posted 11 recalls for KRG devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Programmer, Pacemaker |
| Device class | Class III |
| Regulation | 21 CFR 870.3700 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | PMA |
Compare with all 510(k) review times · Search every KRG clearance
Top KRG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cardiac Pacemakers, Inc. | 7 | 1986-12-05 |
| Intermedics, Inc. | 4 | 1995-03-15 |
| Vitatron Medical BV | 3 | 1985-07-24 |
| Cordis Corp. | 3 | 1981-03-20 |
| Telectronics, Inc. | 2 | 1987-12-17 |
6 more applicants have KRG clearances. See the full list in Caduvo.
Most recent KRG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K933278 | Intermedics, Inc. | INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04 | 1995-03-15 | 624 |
| K884522 | Teletronics, Inc. | MODEL 5650 OPTIMATE PERSONAL PROGRAMMER | 1989-08-25 | 302 |
| K880738 | Medtronic Vascular | MODEL 2331T PATIENT PROGRAMMER | 1988-11-17 | 267 |
| K882429 | Tpl-Cordis, Inc. | MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 4004 | 1988-07-22 | 38 |
| K864712 | Telectronics, Inc. | MODEL 1740 PERSONAL POCKET PROGRAMMER | 1987-12-17 | 379 |
Recalls for KRG devices
11 product recalls in 8 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2025-06-17.
| Year | Recalls |
|---|---|
| 2025 | 2 |
Frequently asked questions
What is FDA product code KRG?
KRG is the FDA product code for programmer, pacemaker. It is a Class III device, regulated under 21 CFR 870.3700 and reviewed by the Cardiovascular panel.
What device class is KRG?
Class III, regulation 21 CFR 870.3700. Typical premarket route: PMA.
How long does a 510(k) take for product code KRG?
Across 25 cleared submissions the average was 132 days from receipt to decision (median 77).
Which companies have the most KRG clearances?
Cardiac Pacemakers, Inc. (7); Intermedics, Inc. (4); Vitatron Medical BV (3); Cordis Corp. (3); Telectronics, Inc. (2).
Have KRG devices been recalled?
Yes: 11 product recalls across 8 recall events; the most recent began 2025-06-17.
Next steps
- Run an FDA pathway report with predicate devices for product code KRG
- Run a recall and safety report across every KRG manufacturer
- Watch product code KRG 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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