Atlas FDA

KRG

25 FDA 510(k) clearances · Product code

77 daysmedian time to decision
302 days90th percentile
25clearances measured

FDA profile

Official device name
Programmer, Pacemaker
Device class
Class III (high risk)
Regulation
21 CFR 870.3700
Medical specialty
Cardiovascular
Adverse events (MAUDE)
2021: 1,700 · 2022: 1,359 · 2023: 1,069 · 2024: 1,545 · 2025: 827 · 2026: 616
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04 (K933278)Intermedics, Inc.1995-03-15
MODEL 5650 OPTIMATE PERSONAL PROGRAMMER (K884522)Teletronics, Inc.1989-08-25
MODEL 2331T PATIENT PROGRAMMER (K880738)Medtronic Vascular1988-11-17
MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 4004 (K882429)Tpl-Cordis, Inc.1988-07-22
MODEL 1740 PERSONAL POCKET PROGRAMMER (K864712)Telectronics, Inc.1987-12-17
MODEL 5600B PROGRAMMER, PACEMAKER (K871986)Telectronics, Inc.1987-06-24
ULTRA SOFTWARE MODULE: MODEL 2016 (K863046)Cardiac Pacemakers, Inc.1986-12-05
PROGRAMMER MODEL 2035/ELECTROGRAM CABLE MODEL 6580 (K863045)Cardiac Pacemakers, Inc.1986-09-29
SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN (K860584)Cardiac Pacemakers, Inc.1986-06-06
DIALOG PROGRAMMER 700 - PROGRAM VERSION 6.37 (K860546)Pacesetter Systems1986-04-23
HEWLETT PACKARDT HP 85 W/ VITATRON PH1 PROGRAM HEA (K844484)Vitatron Medical BV1985-07-24
CERYX6, 611, CERYX 3 311 & CERYX 1 111 (K844485)Vitatron Medical BV1985-04-19
TP 1 (K844483)Vitatron Medical BV1985-04-19
HANDHELD PACEMAKER PROGRAMMER & SOFTWAR (K842364)Cardiac Pacemakers, Inc.1984-09-24
PACEMAKER PROGRAMMER 2030 (K820230)Cardiac Pacemakers, Inc.1982-03-15
FLOW-DIRECTED BALLOON THERMODILUTION (K812761)Nova Medical Specialties1981-11-02
INTERMEDICS PROGRAMMER, MODEL 522-03 (K812813)Intermedics, Inc.1981-10-27
PACEMAKER PROGRAMMER #2010 (K811217)Cardiac Pacemakers, Inc.1981-07-20
CORDIS PACEMAKER PROGRAMMERS 255A & 256A (K810552)Cordis Corp.1981-03-20
EPR-200 PROGRAMMER MODEL 010 (K800376)Biotronik Sales, Inc.1980-04-21
PACEMAKER PROGRAMMER (K792580)Cardiac Pacemakers, Inc.1979-12-19
OMNICOR PROGRAMMER MODEL 222C (K791419)Cordis Corp.1979-11-27
PACEMAKER PROGRAMMER (K790220)Intermedics, Inc.1979-07-31
RATE PROGRAMMER MODEL 520 (K780175)Intermedics, Inc.1978-04-21
OMNICOR PROGRAMMER MODEL 222A (K771855)Cordis Corp.1977-10-07

Track KRG automatically

Every clearance here is in the API, with alerts when new ones post.