Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
BZK — Predicate Candidate Screening
61 FDA 510(k) clearances under this product code; the 50 most recent screened below.
87 daysmedian FDA review time
212 days90th percentile
61clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K192584 | BEACON Caresystem Model 00002144 | Mermaid Care A/S | 2019-12-18 | 90 | 0 |
| K192595 | ExSpiron 2Xi | Respiratory Motion | 2019-12-17 | 88 | 0 |
| K180788 | Gas Module 3 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2018-10-24 | 212 | 0 |
| K173181 | ExSpiron 1Xi | Respiratory Motion, Inc. | 2018-03-16 | 168 | 0 |
| K162131 | ExSpiron 1Xi | Respiratory Motion, Inc. | 2017-05-09 | 281 | 0 |
| K130170 | EXSPIRON 1XI | Respiratory Motion, Inc. | 2013-05-29 | 125 | 0 |
| K120087 | EXSPIRON | Respiratory Motion, Inc. | 2012-09-26 | 259 | 0 |
| K103578 | PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST | Respironics Novametrix, LLC | 2011-06-02 | 178 | 0 |
| K091853 | WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700- | Nspire Health, Inc. | 2009-09-21 | 90 | 0 |
| K092217 | MERCURY VCO2 | Respironics Novametrix, Inc. | 2009-08-21 | 30 | 4 |
| K091459 | PHILIPS NM3 MONITOR, MODEL 7900 | Respironics Novametrix, LLC | 2009-07-28 | 71 | 4 |
| K080652 | MERCURY VCO2 MODULE WITH CAPNOSTAT 5 | Respironics Novametrix, LLC | 2008-06-20 | 105 | 4 |
| K062754 | GAS MODULE SE, MODEL 0998-00-0481-02 | Datascope Corp. | 2006-11-02 | 49 | 0 |
| K051279 | CALDYNE, INC. EXHALOMETER EX100, MODEL EX100 | Caldyne, Inc. | 2005-09-07 | 113 | 0 |
| K983274 | STARTRACK INFANT GRAPHICS MONITOR | Nellcor Puritan Bennett, Inc. | 1998-12-09 | 83 | 0 |
| K972086 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER | Alexander Mfg. Co. | 1997-08-12 | 69 | 0 |
| K932098 | CAPNOMAC ULTIMA ANESTHESIA MONITOR | Datex Division Instrumentarium Corp. | 1993-11-29 | 210 | 0 |
| K931542 | NEWPORT COMPASS EXHALED TIDAL VOLUME MONITOR | Newport Medical Instruments, Inc. | 1993-10-25 | 210 | 0 |
| K921717 | BICORE SMARTVALVE OCCLUSION VALVE | Bicore Monitoring Systems | 1992-11-06 | 211 | 0 |
| K903674 | MODEL 295 ELECTRONIC RESPIROMETER | National Medical Sales, Inc. | 1991-01-04 | 144 | 0 |
| K903959 | NEONATAL METASCOPE | Cybermedic, Inc. | 1990-11-23 | 87 | 0 |
| K901885 | PARTNER VOLUME MONITOR | Bird Products Corp. | 1990-09-27 | 154 | 0 |
| K890932 | CAV 3.0C SOFTWARE PROGRAM | Siemens Life Support Systems | 1989-06-12 | 108 | 0 |
| K884910 | MODEL 1010, CY-MET | Cybermedic, Inc. | 1989-06-12 | 199 | 0 |
| K884959 | RESPITRAK | Non-Invasive Monitoring Systems, Inc. | 1989-06-08 | 191 | 0 |
| K884942 | MONAGHAN RVM, MODEL 761 | Monaghan Medical Corp. | 1989-06-07 | 194 | 0 |
| K890724 | MOFIFICATION BEAR NVM-1 NEONATAL VOLUME MONITOR | Bear Medical Systems, Inc. | 1989-03-30 | 45 | 0 |
| K872660 | BEAR NVM-1 | Bear Medical Systems, Inc. | 1988-02-12 | 220 | 0 |
| K864886 | RESPIGRAPH-RESPISOMNOGRAPH-RESPICENTRAL | Nims/Respitrace Corp. | 1987-03-06 | 84 | 0 |
| K863866 | RESPIRADYNE II(TM) | Chesebrough-Pond'S U.S.A. Co. | 1987-01-28 | 117 | 0 |
| K863538 | RESPICENTRAL(TM) | Dickstein, Shapiro & Morin | 1986-09-24 | 13 | 0 |
| K862687 | OHMEDA 5410 VOLUME MONITOR | Ohmeda Medical | 1986-09-12 | 59 | 0 |
| K862688 | OHMEDA 5420 VOLUME MONITOR | Ohmeda Medical | 1986-09-12 | 59 | 0 |
| K854956 | RESPIGRAPH | Respitrace Corp. | 1986-03-20 | 99 | 0 |
| K853346 | BEAR NICU-1 | Bear Medical Systems, Inc. | 1985-09-11 | 30 | 0 |
| K852692 | RESPITRACE 300SC | Respitrace Corp. | 1985-07-15 | 19 | 0 |
| K843799 | OHMEDA RM311 RESPIROMETER | Ohmeda Medical | 1984-10-04 | 7 | 0 |
| K843800 | OHMEDA RM121 RESPIROMETER | Ohmeda Medical | 1984-10-04 | 7 | 0 |
| K840975 | RICO RESPIRATION MONITOR | J.M. Laboratories, Inc. | 1984-03-30 | 24 | 0 |
| K840453 | MEDISHIELD PVM RESPIROMETER | Ohio Medical Products | 1984-03-02 | 30 | 0 |
| K823780 | RESPITRACE 300SC | Respitrace Corp. | 1984-01-20 | 401 | 0 |
| K823783 | RESPICOMB | Respitrace Corp. | 1984-01-11 | 392 | 0 |
| K832565 | OHIO 5400 VOLUME MONITOR | Airco/Ohio Medical Products | 1983-09-01 | 30 | 0 |
| K822689 | PORTABLE MONITORING & SCREENING SPIROM. | Boehringer Laboratories | 1983-07-12 | 312 | 0 |
| K831237 | SPIROMED RESPIROMETER | Draeger Medical, Inc. | 1983-05-09 | 24 | 0 |
| K830995 | POCKET SPIROMETER | P.K. Morgan Instruments, Inc. | 1983-04-28 | 30 | 0 |
| K823782 | RESPITRACE SYSTEM | Respitrace Corp. | 1983-03-07 | 82 | 0 |
| K823922 | COMPUTERIZED SPIROMETRY SYSTEM | Ohio Medical Products | 1983-02-24 | 58 | 0 |
| K823555 | MAGTARAK RESPIRATORY MONITOR & FLOW SENS | Penlon, Inc. | 1983-01-05 | 35 | 0 |
| K822912 | BEAR VM-90 VENTILATION MONITOR | Bear Medical Systems, Inc. | 1982-11-16 | 46 | 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