Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DRT — Predicate Candidate Screening
339 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
262 days90th percentile
339clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261286 | The Circadia C300 System (C300) | Circadia Health, Inc. | 2026-05-20 | 30 | 0 |
| K252676 | The Circadia C300 System (C300) | Circadia Health, Inc. | 2026-02-03 | 162 | 0 |
| K253388 | Sleepiz One+ (Model 2.5) | Sleepiz AG | 2026-01-28 | 120 | 0 |
| K251364 | Sleepiz One+ (2.5) | Sleepiz AG | 2025-07-29 | 89 | 0 |
| K234003 | The Circadia C200 System | Circadia Technologies, Ltd. | 2024-05-30 | 163 | 0 |
| K232354 | Vios Monitoring System(TM) Model 2050; Vios Central Station | Murata Vios, Inc. | 2024-03-22 | 228 | 0 |
| K231733 | Neteera 130H-Plus Vital Sign Monitoring Sensor | Neteera Technologies , Ltd. | 2024-02-09 | 241 | 0 |
| K223163 | Sleepiz One+ | Sleepiz AG | 2023-08-18 | 315 | 0 |
| K212143 | Neteera 130H/131H Vital Sign Monitoring Sensor | Neteera Technologies , Ltd. | 2022-09-28 | 446 | 0 |
| K202138 | Cardiac Trigger Monitor | Ivy Biomedical Systems, Inc. | 2021-05-14 | 287 | 0 |
| K202464 | Vital Sign Monitoring Sensor (Model :XK300) | Xandar Kardian, Inc. | 2021-04-26 | 242 | 0 |
| K181165 | Philips wearable biosensor-G5 Solution | Connected Sensing- A Division of Philips Medical Systems | 2019-03-07 | 309 | 0 |
| K172586 | Vios Monitoring Systemâ„¢ Model 2050 | Vios Medical, Inc. | 2018-06-22 | 298 | 4 |
| K170828 | Cardiac Trigger Monitor | Ivy Biomedical Systems, Inc. | 2017-05-17 | 58 | 0 |
| K151781 | Cardiac Trigger Monitor, Cardiac & Regulatory Synchronizatio | Ivy Biomedical Systems, Inc. | 2016-05-27 | 331 | 0 |
| K150992 | Vios Monitoring System | Vios Medical, Inc. | 2015-12-16 | 245 | 0 |
| K121860 | ESA615 | Fluke Biomedical | 2013-01-25 | 213 | 0 |
| K121722 | ESA620 ELECTRICAL SAFETY ANALYZER | Fluke Biomedical | 2012-10-11 | 121 | 0 |
| K110429 | PROSIM 4, PROSIM 6, PROSIM 8 | Fluke Biomedical | 2011-09-02 | 199 | 0 |
| K110987 | CARDIAC TRIGGER MONITOR | Ivy Biomedical Systems, Inc. | 2011-07-22 | 105 | 0 |
| K103336 | MPS450 MULTIPARAMETER SIMULATOR | Fluke Biomedical | 2011-04-13 | 149 | 0 |
| K092809 | HRV ACQUIRE | Wr Medical Electronics Co. | 2010-10-19 | 403 | 0 |
| K102174 | ZOLL PROPAQ M | Zoll Medical Corporation, World Wide Headquarters | 2010-09-15 | 44 | 0 |
| K100745 | LIFEBED NETWORK PATIENT VIGILANCE SYSTEM | Hoana Medical, Inc. | 2010-04-15 | 30 | 0 |
| K092037 | LIFEGURNEY NETWORK PATIENT VIGILANCE SYSTEM | Hoana Medical, Inc. | 2009-10-02 | 88 | 0 |
| K091985 | UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE | Ivy Biomedical Systems, Inc. | 2009-07-24 | 22 | 0 |
| K091050 | 506CN PATIENT MONITOR | Criticare Systems, Inc. | 2009-05-27 | 44 | 0 |
| K083534 | LIFEBED NETWORK PATIENT VIGILANCE SYSTEM | Hoana Medical, Inc. | 2009-04-13 | 136 | 0 |
| K083854 | CARDIAC TRIGGER, MODEL: CTM300 | Ivy Biomedical Systems, Inc. | 2009-02-13 | 51 | 0 |
| K082626 | PAM 3000 | Wireless 2000 RF & Uwb Technologies , Ltd. | 2009-01-16 | 129 | 0 |
| K082366 | LIFEBED PATIENT VIGILANCE SYSTEM | Hoana Medical, Inc. | 2008-09-26 | 39 | 0 |
| K063735 | PRESYM TRCG TRACHEOCARDIOGRAM, MODEL 112 | Presym, Inc. | 2007-09-19 | 275 | 0 |
| K060307 | 12 RL ALGORITHM | Ge Medical Systems Information Technologies | 2006-08-04 | 178 | 0 |
| K052446 | LG1 INTELLIGENT MEDICAL VIGILANCE SYSTEM | Hoana Medical, Inc. | 2006-02-02 | 148 | 0 |
| K051038 | 506 PATIENT MONITOR | Ciriticare Systems, Inc. | 2005-08-12 | 109 | 0 |
| K033646 | TRIFIT 700 | Healthfirst Corp. | 2005-03-01 | 467 | 0 |
| K043517 | TRANSMITTER, ZS-940PA SERIES | Nihon Kohden America, Inc. | 2005-02-03 | 45 | 0 |
| K043354 | MODULAR TELEMETRY SYSTEM FOR THE VISION TELEPAK, MODEL 20701 | Invivo Research, Inc. | 2005-01-10 | 35 | 0 |
| K032733 | PM-8000 PATIENT MONITOR, MODEL 8000 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2004-03-03 | 181 | 0 |
| K030656 | ENVAN HEART RATE MONITOR | Envan, LLC | 2003-04-08 | 36 | 0 |
| K023616 | PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES) | Ivy Biomedical Systems, Inc. | 2002-11-04 | 6 | 0 |
| K022435 | 507EL VITAL SIGNS MONITOR | Criticare Systems, Inc. | 2002-08-14 | 20 | 0 |
| K021681 | MICROPAQ, MODELS 402, 404 | Welch Allyn Protocol, Inc. | 2002-07-23 | 62 | 0 |
| K020144 | SIEMENS INFINITY SC 6002XL MODIFICATIONS | Siemens Medical Solutions USA, Inc. | 2002-02-15 | 30 | 0 |
| K012763 | SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CA | Cobe Cardiovascular, Inc. | 2001-11-15 | 90 | 0 |
| K012451 | PROPAQ ENCORE MODELS 202, 204, 206; PROPAQ CS MODELS 242, 24 | Welch Allyn Protocol, Inc. | 2001-08-20 | 19 | 0 |
| K010587 | ACTIVEECG | Active Corp. | 2001-05-16 | 78 | 0 |
| K002061 | A&D MEDICAL TM-2550/TM-2551/TM-2560 VITAL SENSOR MONITOR | A&D Engineering, Inc. | 2001-01-19 | 197 | 0 |
| K001775 | ZOE MEDICAL NIGHTINGALE MONITORING SYSTEM | Zoe Medical, Inc. | 2001-01-12 | 214 | 0 |
| K002725 | MICROPAQ, MODELS 402 AND 404 | Protocol Systems, Inc. | 2000-11-21 | 82 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda