Atlas FDA

DTC

30 FDA 510(k) clearances · Product code

84 daysmedian time to decision
295 days90th percentile
30clearances measured

FDA profile

Official device name
Analyzer, Pacemaker Generator Function
Device class
Class II (moderate risk)
Regulation
21 CFR 870.3630
Medical specialty
Cardiovascular
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 636 · 2022: 218 · 2023: 215 · 2024: 1,077 · 2025: 1,193 · 2026: 46
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
PSA Cable (K170815)Boston Scientific Corporation2017-07-06
PK-141 PATIENT CABLE (K083674)Biotronik, Inc.2009-04-01
SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000 (K011729)Dni Nevada, Inc.2001-08-30
MODEL 4810 ANALYZER OUTPUT ADAPTER (K002497)Pace Medical2000-10-10
EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100 (K961582)North American Technical Services Corp.1996-11-08
EXTERNAL PACEMAKER ANALYZER MODEL PMA-1 (K903966)Bio-Tek Instruments, Inc.1991-06-19
MODEL 5311B A-V PACING SYSTEM ANALYZER (K910595)Medtronic Vascular1991-05-07
CPI MODEL 2215/SEAMED MODEL 3400 (K910223)Seamed Corp.1991-03-19
PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE (K901332)Biotronik, GmbH & Co.1990-05-09
MEDTRONIC MODEL 5401B TEST CABLE (K896632)Medtronic Vascular1989-12-13
MEDTRONIC MODEL 5311B A-V PACING SYSTEM ANALYZER (K884331)Medtronic Vascular1989-01-10
PACER SENSING ANALYZER (PSA 100) (K882327)Oscor Medical Corp.1988-10-06
SEAMED MODEL 3000 (K860462)Seamed Corp.1986-08-19
SEA MED DDD PACING SYSTEM ANALYZER (K851900)Seamed Corp.1985-07-19
MEDTRONIC 5311 PACING SYSTEM ANALYZER (K850077)Medtronic Vascular1985-07-16
CORDIS DUAL-CHAMBER PSA MODEL 296A (PACEMAKER) (K844969)Cordis Corp.1985-05-01
TELECTRONICS MODEL 2401 (K831697)Seamed Corp.1984-09-04
MEDTRONIC A-V PACING SYSTEM ANALYZER (K812262)Medtronic Vascular1982-06-17
ELECTRODE/PACER SYSTEM ANALYZER PMA 400 (K810604)Telectronics, Inc.1981-04-14
SUSI II PACEMAKER SURVEILLANCE MONITOR (K792602)Ela Medical, Inc.1980-03-25
CRITERION II PACING SYSTEM MONITORS (K800286)Dart Medical Equipment1980-03-12
PACING SYSTEM ANALYZER PSA SCE-22 (K791975)Ela Medical, Inc.1980-01-31
MODEL 674 PACER ANALYZER (K792074)Del Mar Avionics1979-12-27
SELF CHECK (K791762)Instromedix, Inc.1979-09-21
PACER-TRACER PULSE WIDTH (K781349)Instromedix, Inc.1978-08-31
ANALYZER, PACER SYSTEM, PSA-5 (K781144)Edwards Pacemaker Systems1978-08-23
EXTERNAL TEST PULSE GENERATOR (K780717)Vitatron Medical BV1978-06-30
MINICLINIC TM (K771922)Instromedix, Inc.1977-11-02
MONITOR, PACEMAKER (K770865)Adcor Electronics, Inc.1977-06-14
PACER SYSTEMS ANALYZER (CORDIS) (K760013)Cordis Corp.1976-07-20

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