FDA product code KRE: Analyzer, Pacemaker Generator Function, Indirect
KRE is the FDA product code for analyzer, pacemaker generator function, indirect. It is a Class II device, regulated under 21 CFR 870.3640 and reviewed by the Cardiovascular panel. FDA has cleared 13 510(k) submissions under KRE, from 11 different applicants. The average 510(k) review took 116 days (median 77).
Classification
| Field | Value |
|---|---|
| Device name | Analyzer, Pacemaker Generator Function, Indirect |
| Device class | Class II |
| Regulation | 21 CFR 870.3640 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every KRE clearance
Top KRE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Paceart, Inc. | 2 | 1992-04-14 |
| Instromedix, Inc. | 2 | 1981-03-17 |
| Medtronic, Inc. | 1 | 2011-06-08 |
| Cygnus, LLC | 1 | 2008-08-22 |
| Medtronic Vascular | 1 | 2003-10-15 |
6 more applicants have KRE clearances. See the full list in Caduvo.
Most recent KRE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K110693 | Medtronic, Inc. | PACEART OPTIMA SYSTEM SOFTWARE | 2011-06-08 | 89 |
| K072950 | Cygnus, LLC | CYGNUS 12 LEAD ECG MODULE | 2008-08-22 | 309 |
| K032926 | Medtronic Vascular | EKG SPEAKS | 2003-10-15 | 23 |
| K922742 | Biotronik, GmbH & Co. | HPM 40 HEART PACEMAKER MONITOR | 1993-03-18 | 283 |
| K915632 | Paceart, Inc. | PACEART CPTS-86/12 | 1992-04-14 | 119 |
Recalls for KRE devices
openFDA lists no recalls for product code KRE.
Frequently asked questions
What is FDA product code KRE?
KRE is the FDA product code for analyzer, pacemaker generator function, indirect. It is a Class II device, regulated under 21 CFR 870.3640 and reviewed by the Cardiovascular panel.
What device class is KRE?
Class II, regulation 21 CFR 870.3640. Typical premarket route: 510(k).
How long does a 510(k) take for product code KRE?
Across 13 cleared submissions the average was 116 days from receipt to decision (median 77).
Which companies have the most KRE clearances?
Paceart, Inc. (2); Instromedix, Inc. (2); Medtronic, Inc. (1); Cygnus, LLC (1); Medtronic Vascular (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KRE
- Run a recall and safety report across every KRE manufacturer
- Watch product code KRE 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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