Product code DRT— Cardiovascular
Cardiac Trigger Monitor
- Classification name
- Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- Device class
- Class 2
- Regulation
- 21 CFR 870.2300
- Advisory panel
- Cardiovascular
- Total cleared
- 339
- First cleared
- Most recent
Market context for product code DRT
FDA has cleared devices under product code DRT between 1976 and 2026, filed by 161 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2024
- 2023
- 2022
- 2021
- 2019
- 2018
- 2017
- 2016
- 2015
- 2013
- 2012
- 2011
- 2010
Top applicants under product code DRT
Adverse events under product code DRT
product code DRT- Death
- 4
- Total
- 4
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code DRT
1–100 of 339- K261286 — The Circadia C300 System (C300)
- K252676 — The Circadia C300 System (C300)
- K253388 — Sleepiz One+ (Model 2.5)
- K251364 — Sleepiz One+ (2.5)
- K234003 — The Circadia C200 System
- K232354 — Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software
- K231733 — Neteera 130H-Plus Vital Sign Monitoring Sensor
- K223163 — Sleepiz One+
- K212143 — Neteera 130H/131H Vital Sign Monitoring Sensor
- K202138 — Cardiac Trigger Monitor
- K202464 — Vital Sign Monitoring Sensor (Model :XK300)
- K181165 — Philips wearable biosensor-G5 Solution
- K172586 — Vios Monitoring System Model 2050
- K170828 — Cardiac Trigger Monitor
- K151781 — Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor
- K150992 — Vios Monitoring System
- K121860 — ESA615
- K121722 — ESA620 ELECTRICAL SAFETY ANALYZER
- K110429 — PROSIM 4, PROSIM 6, PROSIM 8
- K110987 — CARDIAC TRIGGER MONITOR
- K103336 — MPS450 MULTIPARAMETER SIMULATOR
- K092809 — HRV ACQUIRE
- K102174 — ZOLL PROPAQ M
- K100745 — LIFEBED NETWORK PATIENT VIGILANCE SYSTEM
- K092037 — LIFEGURNEY NETWORK PATIENT VIGILANCE SYSTEM
- K091985 — UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE
- K091050 — 506CN PATIENT MONITOR
- K083534 — LIFEBED NETWORK PATIENT VIGILANCE SYSTEM
- K083854 — CARDIAC TRIGGER, MODEL: CTM300
- K082626 — PAM 3000
- K082366 — LIFEBED PATIENT VIGILANCE SYSTEM
- K063735 — PRESYM TRCG TRACHEOCARDIOGRAM, MODEL 112
- K060307 — 12 RL ALGORITHM
- K052446 — LG1 INTELLIGENT MEDICAL VIGILANCE SYSTEM
- K051038 — 506 PATIENT MONITOR
- K033646 — TRIFIT 700
- K043517 — TRANSMITTER, ZS-940PA SERIES
- K043354 — MODULAR TELEMETRY SYSTEM FOR THE VISION TELEPAK, MODEL 20701
- K032733 — PM-8000 PATIENT MONITOR, MODEL 8000
- K030656 — ENVAN HEART RATE MONITOR
- K023616 — PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES)
- K022435 — 507EL VITAL SIGNS MONITOR
- K021681 — MICROPAQ, MODELS 402, 404
- K020144 — SIEMENS INFINITY SC 6002XL MODIFICATIONS
- K012763 — SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM
- K012451 — PROPAQ ENCORE MODELS 202, 204, 206; PROPAQ CS MODELS 242, 244, 246
- K010587 — ACTIVEECG
- K002061 — A&D MEDICAL TM-2550/TM-2551/TM-2560 VITAL SENSOR MONITOR
- K001775 — ZOE MEDICAL NIGHTINGALE MONITORING SYSTEM
- K002725 — MICROPAQ, MODELS 402 AND 404
- K992413 — ESCORT 100/300 SERIES B (ESCORT II) PATIENT MONITOR
- K992411 — ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR
- K984033 — ATLAS MONITOR
- K981378 — DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1
- K974581 — MILLENNIA 3500 SERIES MONITOR WITH ANTHESTHETIC AGENT
- K974178 — PASSPORT 5L-CE MODEL 0998-00-0131XXX
- K973918 — NIHON KOHDEN BSM-1101 AND BSM-1102 PATIENT MONITOR AND ACCESSORIES
- K965158 — HEART PROTECTOR (VER 1996)
- K972787 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M850-P
- K972789 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL600-0016
- K963576 — MOBILE MEDICAL MONITOR (M3(A))
- K952790 — LOG-A-RYTHM MODEL 100 AND MODEL 1001
- K960544 — CARDIO-CARD HOLTER ECG MANAGEMENT SYSTEM
- K950688 — OMIN-TRAK MODEL 3500 SERIES PATIENT MONITORING SYSTEM
- K952474 — EAGLE 3000 PATIENT MONITOR
- K941252 — RESPIRATORY AND CARDIAC SPECTRAL FREQUENCY SIGNAL PROCESSOR
- K944262 — ECG MONITOR
- K945071 — PROPAQ 200 MONITOR
- K940081 — MERCURY
- K943242 — PRO-SPORT HEART RATE MONITOR
- K943243 — PULSE HEART RATE MONITOR
- K934644 — K3 SYSTEM
- K934684 — PAM CARDIAC MONITOR
- K944257 — LIONHEART 3 MULTI-PARAMETER SIMULATOR
- K936051 — OMNI-CENTRAL STATION MONITOR
- K926298 — 520 DISPLAY DRIVER- STATUS I
- K935817 — MEDSIM 300 PATIENT SIMULATOR
- K930004 — ESCORT 100/300 SERIES B PATIENT MONITORS
- K911611 — SYSTEM ATHENA, MODIFICATION
- K921194 — HEWLETT-PACKARD CARDIAC CATHETERIZATION RECORDING
- K915624 — MODIFIED BIOLOG
- K920099 — GYMMAN
- K910665 — MODEL 556 MONITOR W/24-HR. TREND RECALL/MODIFIED
- K914576 — KELLER CARDIAC MONITOR MEDIL KMS870
- K912049 — SYSTEM ATHENA - PRODUCT ENHANCEMENTS
- K911598 — DATASCOPE PASSPORT MONITOR
- K912008 — TRU-VIEW MULTI-CHANNEL DISPLAY
- K910870 — EDENTEC MODEL 3711 DIGITAL RECORDER
- K910852 — 507 NON-INVASIVE VITAL SIGNS MONITOR
- K903512 — FUTURECARE CARELYNK IV SYSTEM
- K905274 — VITALMAX 2100/2200
- K911616 — HORIZON XL
- K911139 — HEWLETT-PACKARD MODELS M1400A, M1402A & M1401A
- K910882 — PROPAQ 102EL, 104EL AND 106EL
- K904696 — WEP-8430A TELEMETRY CENTRAL STATION
- K904353 — CARDIOMATIC MODEL MSC-2001
- K902652 — MORTARA INSTRUMENT MODEL ELI 50
- K900451 — VITALMAX 800 NON-INVASIVE VITAL SIGN MONITOR/PULSE
- K902608 — CARDIOMATIC MODEL MSC-1001
- K901031 — PCI MODEL 2041-PC TELEMETRY MONITOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.