FDA Product Code
FDA Product Code DRT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2300
510(k) Clearances — 340 records · page 1 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254058 | DistaSense(TM) (v1) | Life Detection Technologies | 2026-09-25 | Traditional | PDF ↗ |
| K261286 | The Circadia C300 System (C300) | Circadia Health, Inc. | 2026-05-20 | Special | PDF ↗ |
| K252676 | The Circadia C300 System (C300) | Circadia Health, Inc. | 2026-02-03 | Traditional | PDF ↗ |
| K253388 | Sleepiz One+ (Model 2.5) | Sleepiz AG | 2026-01-28 | Special | PDF ↗ |
| K251364 | Sleepiz One+ (2.5) | Sleepiz AG | 2025-07-29 | Special | PDF ↗ |
| K234003 | The Circadia C200 System | Circadia Technologies, Ltd. | 2024-05-30 | Traditional | PDF ↗ |
| K232354 | Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software | Murata Vios, Inc. | 2024-03-22 | Traditional | PDF ↗ |
| K231733 | Neteera 130H-Plus Vital Sign Monitoring Sensor | Neteera Technologies , Ltd. | 2024-02-09 | Traditional | PDF ↗ |
| K223163 | Sleepiz One+ | Sleepiz AG | 2023-08-18 | Traditional | PDF ↗ |
| K212143 | Neteera 130H/131H Vital Sign Monitoring Sensor | Neteera Technologies , Ltd. | 2022-09-28 | Traditional | PDF ↗ |
| K202138 | Cardiac Trigger Monitor | Ivy Biomedical Systems, Inc. | 2021-05-14 | Traditional | PDF ↗ |
| K202464 | Vital Sign Monitoring Sensor (Model :XK300) | Xandar Kardian, Inc. | 2021-04-26 | Traditional | PDF ↗ |
| K181165 | Philips wearable biosensor-G5 Solution | Connected Sensing- A Division of Philips Medical Systems | 2019-03-07 | Traditional | PDF ↗ |
| K172586 | Vios Monitoring System Model 2050 | Vios Medical, Inc. | 2018-06-22 | Traditional | PDF ↗ |
| K170828 | Cardiac Trigger Monitor | Ivy Biomedical Systems, Inc. | 2017-05-17 | Abbreviated | PDF ↗ |
| K151781 | Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor | Ivy Biomedical Systems, Inc. | 2016-05-27 | Abbreviated | PDF ↗ |
| K150992 | Vios Monitoring System | Vios Medical, Inc. | 2015-12-16 | Traditional | PDF ↗ |
| K121860 | ESA615 | Fluke Biomedical | 2013-01-25 | Traditional | PDF ↗ |
| K121722 | ESA620 ELECTRICAL SAFETY ANALYZER | Fluke Biomedical | 2012-10-11 | Traditional | PDF ↗ |
| K110429 | PROSIM 4, PROSIM 6, PROSIM 8 | Fluke Biomedical | 2011-09-02 | Traditional | PDF ↗ |
| K110987 | CARDIAC TRIGGER MONITOR | Ivy Biomedical Systems, Inc. | 2011-07-22 | Special | PDF ↗ |
| K103336 | MPS450 MULTIPARAMETER SIMULATOR | Fluke Biomedical | 2011-04-13 | Traditional | PDF ↗ |
| K092809 | HRV ACQUIRE | Wr Medical Electronics Co. | 2010-10-19 | Abbreviated | PDF ↗ |
| K102174 | ZOLL PROPAQ M | Zoll Medical Corporation, World Wide Headquarters | 2010-09-15 | Traditional | PDF ↗ |
| K100745 | LIFEBED NETWORK PATIENT VIGILANCE SYSTEM | Hoana Medical, Inc. | 2010-04-15 | Special | PDF ↗ |
| K092037 | LIFEGURNEY NETWORK PATIENT VIGILANCE SYSTEM | Hoana Medical, Inc. | 2009-10-02 | Traditional | PDF ↗ |
| K091985 | UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE | Ivy Biomedical Systems, Inc. | 2009-07-24 | Special | PDF ↗ |
| K091050 | 506CN PATIENT MONITOR | Criticare Systems, Inc. | 2009-05-27 | Special | PDF ↗ |
| K083534 | LIFEBED NETWORK PATIENT VIGILANCE SYSTEM | Hoana Medical, Inc. | 2009-04-13 | Traditional | PDF ↗ |
| K083854 | CARDIAC TRIGGER, MODEL: CTM300 | Ivy Biomedical Systems, Inc. | 2009-02-13 | Special | PDF ↗ |
| K082626 | PAM 3000 | Wireless 2000 RF & Uwb Technologies , Ltd. | 2009-01-16 | Traditional | PDF ↗ |
| K082366 | LIFEBED PATIENT VIGILANCE SYSTEM | Hoana Medical, Inc. | 2008-09-26 | Special | PDF ↗ |
| K063735 | PRESYM TRCG TRACHEOCARDIOGRAM, MODEL 112 | Presym, Inc. | 2007-09-19 | Traditional | PDF ↗ |
| K060307 | 12 RL ALGORITHM | Ge Medical Systems Information Technologies | 2006-08-04 | Traditional | PDF ↗ |
| K052446 | LG1 INTELLIGENT MEDICAL VIGILANCE SYSTEM | Hoana Medical, Inc. | 2006-02-02 | Traditional | PDF ↗ |
| K051038 | 506 PATIENT MONITOR | Ciriticare Systems, Inc. | 2005-08-12 | Traditional | PDF ↗ |
| K033646 | TRIFIT 700 | Healthfirst Corp. | 2005-03-01 | Traditional | PDF ↗ |
| K043517 | TRANSMITTER, ZS-940PA SERIES | Nihon Kohden America, Inc. | 2005-02-03 | Abbreviated | PDF ↗ |
| K043354 | MODULAR TELEMETRY SYSTEM FOR THE VISION TELEPAK, MODEL 20701 | Invivo Research, Inc. | 2005-01-10 | Special | PDF ↗ |
| K032733 | PM-8000 PATIENT MONITOR, MODEL 8000 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2004-03-03 | Traditional | PDF ↗ |
| K030656 | ENVAN HEART RATE MONITOR | Envan, LLC | 2003-04-08 | Traditional | PDF ↗ |
| K023616 | PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES) | Ivy Biomedical Systems, Inc. | 2002-11-04 | Special | PDF ↗ |
| K022435 | 507EL VITAL SIGNS MONITOR | Criticare Systems, Inc. | 2002-08-14 | Special | PDF ↗ |
| K021681 | MICROPAQ, MODELS 402, 404 | Welch Allyn Protocol, Inc. | 2002-07-23 | Special | PDF ↗ |
| K020144 | SIEMENS INFINITY SC 6002XL MODIFICATIONS | Siemens Medical Solutions USA, Inc. | 2002-02-15 | Special | PDF ↗ |
| K012763 | SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM | Cobe Cardiovascular, Inc. | 2001-11-15 | Abbreviated | PDF ↗ |
| K012451 | PROPAQ ENCORE MODELS 202, 204, 206; PROPAQ CS MODELS 242, 244, 246 | Welch Allyn Protocol, Inc. | 2001-08-20 | Special | PDF ↗ |
| K010587 | ACTIVEECG | Active Corp. | 2001-05-16 | Abbreviated | PDF ↗ |
| K002061 | A&D MEDICAL TM-2550/TM-2551/TM-2560 VITAL SENSOR MONITOR | A&D Engineering, Inc. | 2001-01-19 | Traditional | PDF ↗ |
| K001775 | ZOE MEDICAL NIGHTINGALE MONITORING SYSTEM | Zoe Medical, Inc. | 2001-01-12 | Traditional | PDF ↗ |
| K002725 | MICROPAQ, MODELS 402 AND 404 | Protocol Systems, Inc. | 2000-11-21 | Traditional | PDF ↗ |
| K992413 | ESCORT 100/300 SERIES B (ESCORT II) PATIENT MONITOR | Medical Data Electronics | 1999-08-19 | Special | PDF ↗ |
| K992411 | ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR | Medical Data Electronics | 1999-08-18 | Special | PDF ↗ |
| K984033 | ATLAS MONITOR | Welch Allyn, Inc. | 1999-07-08 | Traditional | PDF ↗ |
| K981378 | DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1 | Datex-Engstrom, Inc. | 1998-11-03 | Traditional | PDF ↗ |
| K974581 | MILLENNIA 3500 SERIES MONITOR WITH ANTHESTHETIC AGENT | Invivo Research, Inc. | 1998-10-28 | Traditional | PDF ↗ |
| K974178 | PASSPORT 5L-CE MODEL 0998-00-0131XXX | Datascope Corp. | 1998-06-26 | Traditional | PDF ↗ |
| K973918 | NIHON KOHDEN BSM-1101 AND BSM-1102 PATIENT MONITOR AND ACCESSORIES | Nihon Kohden America, Inc. | 1998-01-13 | Traditional | PDF ↗ |
| K965158 | HEART PROTECTOR (VER 1996) | N.P.N.T., Inc. | 1997-12-09 | Traditional | PDF ↗ |
| K972787 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M850-P | Alexander Mfg. Co. | 1997-10-17 | Traditional | PDF ↗ |
| K972789 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL600-0016 | Alexander Mfg. Co. | 1997-10-17 | Traditional | PDF ↗ |
| K963576 | MOBILE MEDICAL MONITOR (M3(A)) | Scientific Applications | 1997-02-28 | Traditional | PDF ↗ |
| K952790 | LOG-A-RYTHM MODEL 100 AND MODEL 1001 | Nian-Crae, Inc. | 1996-10-17 | Traditional | PDF ↗ |
| K960544 | CARDIO-CARD HOLTER ECG MANAGEMENT SYSTEM | Nasiff Assoc., Inc. | 1996-08-07 | Traditional | PDF ↗ |
| K950688 | OMIN-TRAK MODEL 3500 SERIES PATIENT MONITORING SYSTEM | Safety Tek Corp. | 1996-04-18 | Traditional | PDF ↗ |
| K952474 | EAGLE 3000 PATIENT MONITOR | Marquette Electronics, Inc. | 1995-10-19 | Traditional | PDF ↗ |
| K941252 | RESPIRATORY AND CARDIAC SPECTRAL FREQUENCY SIGNAL PROCESSOR | Ansar | 1995-09-20 | Traditional | PDF ↗ |
| K944262 | ECG MONITOR | Fukuda Denshi USA, Inc. | 1995-05-12 | Traditional | PDF ↗ |
| K945071 | PROPAQ 200 MONITOR | Protocol Systems, Inc. | 1995-05-10 | Traditional | PDF ↗ |
| K940081 | MERCURY | Mennen Medical, Inc. | 1995-04-12 | Traditional | PDF ↗ |
| K943242 | PRO-SPORT HEART RATE MONITOR | Sensor Dynamics, Inc. | 1995-03-10 | Traditional | PDF ↗ |
| K943243 | PULSE HEART RATE MONITOR | Sensor Dynamics, Inc. | 1995-03-10 | Traditional | PDF ↗ |
| K934644 | K3 SYSTEM | Astro-Med, Inc. | 1994-11-01 | Traditional | PDF ↗ |
| K934684 | PAM CARDIAC MONITOR | Technology Transfer, Inc. | 1994-10-17 | Traditional | PDF ↗ |
| K944257 | LIONHEART 3 MULTI-PARAMETER SIMULATOR | Bio-Tek Instruments, Inc. | 1994-09-21 | Traditional | PDF ↗ |
| K936051 | OMNI-CENTRAL STATION MONITOR | Invivo Research, Inc. | 1994-07-06 | Traditional | PDF ↗ |
| K926298 | 520 DISPLAY DRIVER- STATUS I | Vidco, Inc. | 1994-05-04 | Traditional | PDF ↗ |
| K935817 | MEDSIM 300 PATIENT SIMULATOR | Dynatech/Nevada, Inc. | 1994-01-18 | Traditional | PDF ↗ |
| K930004 | ESCORT 100/300 SERIES B PATIENT MONITORS | Medical Data Electronics | 1993-06-23 | Traditional | PDF ↗ |
| K911611 | SYSTEM ATHENA, MODIFICATION | S & W Medico Teknik | 1993-02-05 | Traditional | PDF ↗ |
| K921194 | HEWLETT-PACKARD CARDIAC CATHETERIZATION RECORDING | Hewlett-Packard Co. | 1992-11-09 | Traditional | PDF ↗ |
| K915624 | MODIFIED BIOLOG | Micromedical Industries, Ltd. | 1992-03-27 | Traditional | PDF ↗ |
| K920099 | GYMMAN | Lumiscope Co., Inc. | 1992-03-09 | Traditional | PDF ↗ |
| K910665 | MODEL 556 MONITOR W/24-HR. TREND RECALL/MODIFIED | Ge Medical Systems Information Technologies | 1991-12-31 | Traditional | PDF ↗ |
| K914576 | KELLER CARDIAC MONITOR MEDIL KMS870 | Keller Medical Specialties Products, Inc. | 1991-12-30 | Traditional | PDF ↗ |
| K912049 | SYSTEM ATHENA - PRODUCT ENHANCEMENTS | S & W Medico Teknik | 1991-12-05 | Traditional | PDF ↗ |
| K911598 | DATASCOPE PASSPORT MONITOR | Datascope Corp. | 1991-10-15 | Traditional | PDF ↗ |
| K912008 | TRU-VIEW MULTI-CHANNEL DISPLAY | General Devices | 1991-10-09 | Traditional | PDF ↗ |
| K910870 | EDENTEC MODEL 3711 DIGITAL RECORDER | Edentec Corp. | 1991-08-29 | Traditional | PDF ↗ |
| K910852 | 507 NON-INVASIVE VITAL SIGNS MONITOR | Criticare Systems, Inc. | 1991-07-30 | Traditional | PDF ↗ |
| K903512 | FUTURECARE CARELYNK IV SYSTEM | Futurecare Systems, Inc. | 1991-07-18 | Traditional | PDF ↗ |
| K905274 | VITALMAX 2100/2200 | Pace Tech, Inc. | 1991-07-17 | Traditional | PDF ↗ |
| K911616 | HORIZON XL | Mennen Medical, Inc. | 1991-07-10 | Traditional | PDF ↗ |
| K911139 | HEWLETT-PACKARD MODELS M1400A, M1402A & M1401A | Hewlett-Packard Co. | 1991-06-11 | Traditional | PDF ↗ |
| K910882 | PROPAQ 102EL, 104EL AND 106EL | Protocol Systems, Inc. | 1991-05-08 | Traditional | PDF ↗ |
| K904696 | WEP-8430A TELEMETRY CENTRAL STATION | Nihon Kohden America, Inc. | 1991-02-07 | Traditional | PDF ↗ |
| K904353 | CARDIOMATIC MODEL MSC-2001 | Medical Systems Corp. | 1990-12-20 | Traditional | PDF ↗ |
| K902652 | MORTARA INSTRUMENT MODEL ELI 50 | Mortara Instrument, Inc. | 1990-08-23 | Traditional | PDF ↗ |
| K900451 | VITALMAX 800 NON-INVASIVE VITAL SIGN MONITOR/PULSE | Pace Tech, Inc. | 1990-07-18 | Traditional | PDF ↗ |
| K902608 | CARDIOMATIC MODEL MSC-1001 | Medical Systems Corp. | 1990-07-13 | Traditional | PDF ↗ |
Product code DRT · Class II · Cardiovascular. Data: openFDA.