KRE
13 FDA 510(k) clearances · Product code
77 daysmedian time to decision
283 days90th percentile
13clearances measured
FDA profile
- Official device name
- Analyzer, Pacemaker Generator Function, Indirect
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3640
- Medical specialty
- Cardiovascular
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1996: 1 · 2021: 14
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| PACEART OPTIMA SYSTEM SOFTWARE (K110693) | Medtronic, Inc. | 2011-06-08 |
| CYGNUS 12 LEAD ECG MODULE (K072950) | Cygnus, LLC | 2008-08-22 |
| EKG SPEAKS (K032926) | Medtronic Vascular | 2003-10-15 |
| HPM 40 HEART PACEMAKER MONITOR (K922742) | Biotronik, GmbH & Co. | 1993-03-18 |
| PACEART CPTS-86/12 (K915632) | Paceart, Inc. | 1992-04-14 |
| PACEVIEW (K895535) | Micromedical | 1990-03-19 |
| PACEMAKER FUNCTION ANALYZER (K870909) | Paceart, Inc. | 1987-04-27 |
| PACEMAKER SYS ANALYZER #384 (K833647) | Pacesetter Systems | 1983-12-16 |
| PACEMAKER SYS. ANALYZER 378 (K832959) | Siemens Elema AB | 1983-11-14 |
| CARDIOMEMO (K803286) | Instromedix, Inc. | 1981-03-17 |
| ELECTRONIC PACEMAKER WAVEFORM ANALYZER (K800696) | Instromedix, Inc. | 1980-08-14 |
| ULTRA-CHEK PACEMAKER MONITOR (K801022) | Powers Medical Systmes | 1980-06-17 |
| PACE-PULSE/COMPUTRAC (K800782) | Bib, Inc. | 1980-05-28 |
Track KRE automatically
Every clearance here is in the API, with alerts when new ones post.