Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
BZQ — Predicate Candidate Screening
176 FDA 510(k) clearances under this product code; the 50 most recent screened below.
122 daysmedian FDA review time
315 days90th percentile
176clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253274 | BedDot (G1) | Intelligent Dots, LLC | 2026-06-25 | 269 | 0 |
| K251326 | Respiration Rate algorithm | Edwards Lifesciences, LLC | 2026-06-11 | 408 | 0 |
| K250093 | Linshom Continuous Predictive Respiratory Monitoring System | Linshom Medical, Inc. | 2025-09-26 | 255 | 0 |
| K250934 | Respiree Cardio- Respiratory Monitor System | Respiree Pte, Ltd. | 2025-08-05 | 130 | 0 |
| K243183 | RTMsense Respiratory Monitoring System | Rtm Vital Signs, LLC | 2025-06-27 | 270 | 0 |
| K243966 | FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) | Faceheart Corp. | 2025-04-09 | 107 | 0 |
| K242001 | Philips VSC-MEDlib | Philips Medical Systems Nederland B.V. | 2025-04-04 | 269 | 0 |
| K233953 | Makani Science™ Respiration Monitoring System | Makani Science, Inc. | 2025-03-28 | 469 | 0 |
| K242798 | Airmod | Heroic Faith International , Ltd. | 2025-02-28 | 165 | 0 |
| K240271 | Linshom Continuous Predictive Respiratory Monitoring System | Linshom Medical, Inc. | 2024-09-11 | 224 | 0 |
| K223681 | Respiree Cardio-Respiratory Monitor | Respiree Pte, Ltd. | 2023-03-08 | 90 | 0 |
| K221555 | Dozee VS | Turtle Shell Technologies Private Limited | 2022-12-15 | 198 | 0 |
| K223246 | Hillrom Heart and Respiration Rate Monitoring System powered | Baxter Healthcare Corproration | 2022-11-18 | 29 | 0 |
| K220111 | RespiraSense | Pmd Solutions | 2022-10-07 | 267 | 0 |
| K211387 | Breathe Easy Mobile Respiratory Monitor (MRM) | Sound Life Sciences, Inc. | 2021-11-23 | 202 | 0 |
| K202018 | Hill-Rom Heart and Respiration Rate Monitoring System: Singl | Hill-Rom, Inc. | 2021-03-04 | 226 | 0 |
| K200445 | The C100 Contactless Breathing Monitor | Circadia Technologies, Ltd. | 2020-06-24 | 121 | 0 |
| K190734 | Linshom Respiratory Monitoring Device (LRMD) | Linshom Management, LLC | 2020-01-30 | 315 | 0 |
| K190775 | The RHEA Vital Sign Vigilance System | Shenzhen Fiber Medical Technology Co. , Ltd. | 2019-12-19 | 268 | 0 |
| K173976 | Masimo Acoustic Respiration Sensors, infant and neonate | Masimo Corporation | 2018-09-05 | 250 | 0 |
| K180079 | Hill-Rom Vitals Monitoring System powered by EarlySense: Sen | Hill-Rom, Inc. | 2018-05-07 | 117 | 0 |
| K171836 | EarlySense Bed Sensing Unit | Earlysense, Ltd. | 2018-01-04 | 198 | 0 |
| K152911 | EarlySense Insight Sytem | Earlysense, Ltd. | 2016-05-06 | 217 | 0 |
| K151940 | Thora-3Di, Model T-01 | Pneumacare Limited | 2016-03-10 | 240 | 0 |
| K133661 | CHAIR SENSING UNIT FOR EARLYSENSE SYSTEM | Earlysense, Ltd. | 2014-06-13 | 196 | 0 |
| K132320 | INTELLIVUE CL RESPIRATION POD | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2014-03-26 | 244 | 0 |
| K130570 | NEUROVISION MEDICAL MOTION SENSOR | Neurovision Medical Products, Inc. | 2013-12-26 | 297 | 0 |
| K131379 | EARLYSENSE | Earlysense, Ltd. | 2013-12-18 | 218 | 0 |
| K122223 | NEW: INTELLIVUE CL RESPIRATION POD NEW: SPECIALIZED ASSESSOR | Philips Medizin Systeme Boeblingen GmbH | 2013-04-12 | 261 | 0 |
| K120465 | EARLYSENSE (EVERON) SYSTEM | Earlysense, Ltd. | 2012-06-08 | 114 | 0 |
| K111933 | COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERS | Covidien | 2012-03-15 | 251 | 0 |
| K103631 | SLEEPMINDER BREATHING FREQUENCY INDICATOR | Biancamed Limited | 2011-07-21 | 220 | 0 |
| K100773 | KAI SPOT MODEL KMS 200 | Kai Medical, Inc. | 2010-06-23 | 97 | 0 |
| K092062 | EVERON 1.0 | Earlysense, Ltd. | 2010-05-24 | 320 | 0 |
| K092685 | PNEUMOTHERML, MODEL: 5800 | Salter Labs | 2009-11-24 | 83 | 0 |
| K090273 | KAI SENSORS NON-CONTACT RESPIRATORY RATE SPOT CHECK, MODEL 1 | Kai Sensors, Inc. | 2009-06-05 | 121 | 0 |
| K082465 | EVERON | Earlysense, Ltd. | 2009-03-25 | 210 | 0 |
| K080922 | SALTER LABS ORAL/NASAL THERMAL AIRFLOW SENSOR | Salter Labs, Division of Regulatory Affairs | 2008-07-25 | 115 | 1 |
| K070375 | EARLYSENSE ES-16 SYSTEM | Earlysense, Ltd. | 2007-11-15 | 280 | 0 |
| K062883 | GEREONICS ULTRA-PIEZO LIMB MOVEMENT SENSOR | Gereonics, Inc. | 2007-06-13 | 260 | 0 |
| K051779 | ANDROFLOW - RESPIRATORY RATE MONITOR | Andromed, Inc. | 2005-09-30 | 91 | 0 |
| K040605 | DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 | Dymedix, Inc. | 2004-04-26 | 49 | 0 |
| K003704 | OPTOVENT RESPONS, OPTOVENT RENEE (OPTOVENT RESPONS WITHOUT P | Optovent AB | 2001-02-05 | 66 | 0 |
| K001743 | ULTIMA SMARTBELT, MODEL 0560 | Braebon Medical Corp. | 2000-08-25 | 78 | 0 |
| K001030 | RESPIRATORY BELT SENSOR, MODEL 6000S; LIMB MOVEMENT SENSOR, | Dymedix, Inc. | 2000-05-11 | 42 | 0 |
| K991411 | GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR | Gereonics, Inc. | 1999-04-28 | 33 | 0 |
| K983449 | GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR | Gereonics, Inc. | 1999-02-08 | 131 | 0 |
| K981725 | OPTOVENT RESPIRATORY MONITOR MODEL NUMBER RR 9700 | Optovent, Inc. | 1999-02-02 | 263 | 0 |
| K984431 | ULTIMA AIRFLOW PRESSURE SENSOR | Braebon Medical Corp. | 1998-12-30 | 19 | 0 |
| K982550 | BROWSER (EVENT SOFTWARE) MODEL # 4500E | Respironics, Inc. | 1998-10-05 | 75 | 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