Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
BZG — Predicate Candidate Screening
228 FDA 510(k) clearances under this product code; the 50 most recent screened below.
146 daysmedian FDA review time
314 days90th percentile
228clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251777 | MESI mTABLET SPIRO | Mesi D.O.O. | 2026-03-02 | 265 | 0 |
| K241843 | TD-7301 Spirometer (TD-7301) | Gostar Co., Ltd. | 2024-11-20 | 147 | 0 |
| K231416 | Air Next (NVD-02) | Nuvoair AB | 2024-01-18 | 247 | 0 |
| K230501 | Spirobank Oxi | Mir Medical International Research USA | 2023-12-15 | 294 | 0 |
| K230178 | EasyOne Sky Spirometer | Ndd Medizintechnik AG | 2023-10-19 | 269 | 0 |
| K222525 | Alveoair Digital Spirometer | Roundworks Technologies Private Limited | 2023-08-28 | 371 | 0 |
| K222443 | Air Smart Extra Spirometer | Feellife Health, Inc. | 2023-08-09 | 362 | 0 |
| K213754 | SpiroHome Personal, SpiroHome Clinic | Inofab Saglik Teknolojileri A.S | 2023-06-12 | 559 | 0 |
| K213872 | ComPAS2 | Morgan Scientific, Inc. | 2022-07-15 | 214 | 0 |
| K212938 | Vitalograph Model 6000 Alpha | Vitalograph Ireland, Ltd. | 2022-01-26 | 133 | 0 |
| K201493 | Spirometer | Mehow Innovative, Ltd. | 2021-06-10 | 371 | 0 |
| K202837 | GoSpiro | Monitored Therapeutics, Inc. | 2020-12-04 | 70 | 0 |
| K201562 | Spirotrac | Vitalograph Ireland, Ltd. | 2020-10-14 | 126 | 0 |
| K201002 | Safey Pocket Spirometer | Safey Medical Devices Pvt, Ltd. | 2020-07-30 | 105 | 0 |
| K200550 | Vitalograph Model 2120 In2itive eDiary | Vitalograph Ireland, Ltd. | 2020-07-27 | 146 | 0 |
| K183089 | Air Next | Nuvoair AB | 2020-01-02 | 422 | 0 |
| K183479 | Asthma Monitor AM3 | Eresearch Technology | 2019-10-03 | 290 | 0 |
| K191013 | Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometr | Welch Allyn, Inc. | 2019-09-10 | 146 | 1 |
| K190568 | ComPAS2 (Computerized Pulmonary Analysis System) | Morgan Scientific, Inc. | 2019-06-06 | 92 | 0 |
| K180011 | Pulmonx Chartis Tablet Console | Pulmonx Corporation | 2018-07-13 | 192 | 0 |
| K163249 | GoSpiro | Monitored Therapeutics, Inc. | 2017-03-24 | 126 | 0 |
| K161536 | EasyOne Air Spirometer | Ndd Medizintechnik AG | 2017-01-05 | 216 | 0 |
| K161676 | Q13 SPIROLYSER® | Fim Medical | 2016-10-20 | 125 | 0 |
| K160116 | SpiroScout | Ganshorn Medizin Electronic GmbH | 2016-10-07 | 262 | 0 |
| K160253 | Vitalograph Model 6300 micro | Vitalograph (Ireland) , Ltd. | 2016-08-26 | 207 | 0 |
| K150515 | IQSense Flow Sensor Mouthpiece | Sdi Diagnostics, Inc. | 2016-01-12 | 316 | 0 |
| K142642 | Vitalograph Model 6600 Compact | Vitalograph (Ireland) , Ltd. | 2015-06-30 | 286 | 0 |
| K142812 | Vitalograph Model 6800 Pneumotrac | Vitalograph (Ireland) , Ltd. | 2015-06-29 | 273 | 0 |
| K120577 | MEDIKRO SPIROSTAR, M929 Medikro Spirostar USB and M921 Medik | Medikro OY | 2015-06-24 | 1213 | 0 |
| K150137 | SpiroThor | Cohero Health, LLC | 2015-05-27 | 125 | 0 |
| K141793 | PULMONE MINIBOXPFT 2.0 | Pulmone Advanced Medical Devices, Ltd. | 2015-03-06 | 247 | 0 |
| K141936 | MICROBLAB, MICROLOOP | Carefusion Germany 234 GmbH | 2014-12-29 | 165 | 0 |
| K142303 | NeumoFilt Ergo/Neumo Filt BiteOn | Medical Respiratory Devices S.L. | 2014-11-20 | 94 | 0 |
| K141546 | VITALOGRAPH MODEL 7000 SPIROTRAC | Vitalograph (Ireland) , Ltd. | 2014-09-03 | 85 | 0 |
| K133428 | MEDIKRO NANO, MEDIKRO PRIMO AND MEDIKRO PRO | Medikro OY | 2014-05-21 | 194 | 0 |
| K133722 | ASTHMA MONITOR AM3 | Eresearch Technology | 2014-05-08 | 154 | 0 |
| K130322 | SPM-300 | Bionet Co., Ltd. | 2013-11-15 | 280 | 0 |
| K130784 | SPIROTEL | Mir Medical Intl. Research Srl | 2013-10-30 | 223 | 0 |
| K123896 | CCS-200 SPIROMETER | Benson Medical Instruments Co. | 2013-09-10 | 266 | 0 |
| K122384 | MINISPIR | Mir Medical Intl. Research Srl | 2012-10-04 | 59 | 0 |
| K120880 | ORBIT | National Biomedical, LLC Dba Qrs Diagnostic | 2012-04-19 | 27 | 0 |
| K113096 | MICRO I | Carefusion Germany 234 GmbH | 2012-04-13 | 177 | 0 |
| K103530 | SPIRODOC | Medical International Research USA, Inc. | 2011-11-21 | 355 | 0 |
| K111764 | CHARTIS CONSOLE | Pulmonx, Inc. | 2011-11-10 | 140 | 0 |
| K103575 | SPIRO PD | Pmd Healthcare | 2011-11-09 | 338 | 0 |
| K111587 | ALERKAN SPIROMETRY FILTER | Alerkan, Ltd. | 2011-10-20 | 135 | 0 |
| K100928 | MICRO DIARY SPIROMETER | Viasys Respiratory Care, Inc. | 2011-03-07 | 336 | 0 |
| K101873 | MASTERSCREEN IOS | Carefusion Germany 234 GmbH | 2011-02-10 | 219 | 0 |
| K100687 | VITALOGRAPH HAND HELD SPIROMETER, MODEL 2120 | Vitalograph (Ireland) , Ltd. | 2010-10-16 | 220 | 0 |
| K092813 | ASTRASONIC SPIROMETER, MODEL 29-8000 | Sdi Diagnostics, Inc. | 2010-07-16 | 305 | 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