Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
BZC · Predicate Candidate Screening
90 FDA 510(k) clearances under this product code; the 50 most recent screened below.
102 daysmedian FDA review time
374 days90th percentile
90clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240293 | STS | Techbopulm, Ltd. | 2024-09-17 | 229 | 0 |
| K183567 | Vyntus/SentrySuite Product Line | Vyaire Medical | 2019-08-23 | 245 | 0 |
| K190853 | Vyntus BODY | Vyaire Medical, Inc. | 2019-08-16 | 136 | 0 |
| K181524 | Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus | Vyaire Medical, Inc. | 2018-11-30 | 172 | 0 |
| K162515 | COSMED K5 Wearable Metabolic Technology | Cosmed Srl | 2017-06-20 | 285 | 0 |
| K161295 | MiniBox + | Pulmone Advanced Medical Devices, Ltd. | 2016-10-21 | 165 | 0 |
| K150810 | Vyntus / SentrySuite Product Line | Carefusion Germany 234 GmbH | 2015-08-14 | 141 | 1 |
| K133925 | VYNTUS/ SENTRYSUITE PRODUCT LINE | Carefusion Germany 234 GmbH | 2014-08-22 | 242 | 0 |
| K133051 | PULMONE MINIBOX PFT TM | Pulmone Advanced Medical Devices, Ltd. | 2014-05-02 | 217 | 0 |
| K102047 | LCI OPTION FOR INNOCOR | Innovision A/S | 2011-11-01 | 468 | 1 |
| K072323 | MASTERSCREEN & OXYCON CPX | Viasys Healthcare GmbH | 2007-10-10 | 51 | 0 |
| K052328 | ZAN LUNG-FUNCTION LAB | Zan Messgerate GmbH | 2005-12-22 | 119 | 0 |
| K040698 | MASTERSCREEN CPX AND OXYCON CPX | Viasys Healthcare GmbH | 2004-04-07 | 21 | 0 |
| K023120 | OXYCON MOBILE | Erich Jaeger GmbH | 2003-11-12 | 419 | 0 |
| K011344 | INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAP | Collins Medical, Inc. | 2002-05-17 | 380 | 0 |
| K001631 | CORTEX METAMAX | Cortex Biophysik GmbH | 2001-02-22 | 272 | 0 |
| K001174 | COSMED QUARK | Cosmed Srl | 2001-01-11 | 275 | 0 |
| K001502 | AEROSOL PROVOCATION SYSTEM APS PRO, MODEL APS PRO | Erich Jaeger GmbH | 2000-07-12 | 58 | 0 |
| K992214 | OXYCON PRO | Erich Jaeger B.V. | 2000-02-22 | 236 | 0 |
| K982499 | COSMO PLUS WITH NICO, MODEL 8200 | Novametrix Medical Systems, Inc. | 1998-10-16 | 88 | 1 |
| K982487 | CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MONITOR MET | Cardiopulmonary Technologies, Inc. | 1998-10-14 | 89 | 0 |
| K970840 | INTELLIFLOW RESPIRATORY ANALYZER | Simtec, Inc. | 1997-11-26 | 264 | 0 |
| K963373 | COSMED K4 | Cosmed Srl | 1997-09-10 | 379 | 0 |
| K964360 | VENT(VENTCHECK) HANDHELD RESPIRATORY/MECHANICS MONITOR MODEL | Novametrix Medical Systems, Inc. | 1997-04-04 | 154 | 0 |
| K954730 | BENCHMARK TRANSFER TEST | P.K. Morgan , Ltd. | 1997-04-01 | 533 | 0 |
| K964939 | THE PORTABLE FAMILY - MEDI-FACTS DX1 PORTABLE LITE AND DX1 P | Creative Biomedics, Inc. | 1997-03-06 | 86 | 0 |
| K963380 | CO 2 SMO PLUS | Novametrix Medical Systems, Inc. | 1997-01-22 | 148 | 3 |
| K960121 | AUTOLINK BODY PLETHYSMOGRAPH | P.K. Morgan , Ltd. | 1997-01-09 | 364 | 0 |
| K953990 | TRANSFLOW TEST | P.K. Morgan , Ltd. | 1996-12-09 | 473 | 0 |
| K960831 | VENTRAK RMMS 1550 | Novametrix Medical Systems, Inc. | 1996-05-29 | 90 | 0 |
| K952542 | ACKRAD ESOPHAGEAL BALLOON CATHETER SET | Ackrad Laboratories | 1996-04-23 | 336 | 0 |
| K946077 | DIRECTIONAL CONTROL VALVES INFLATABLE BALLOON-TYPE AND CONTR | Hans Rudolph, Inc. | 1995-09-15 | 276 | 0 |
| K951157 | DX1-PORTABLE | Creative Biomedics, Inc. | 1995-08-11 | 150 | 0 |
| K941843 | MMS-2400 | Parvo Medics, Inc. | 1995-06-16 | 428 | 0 |
| K945213 | TEEN 100 | Aerosport, Inc. | 1995-05-25 | 212 | 0 |
| K942864 | LUNG DIFFUSION | Nordan Smith Welding Supplies | 1995-03-03 | 259 | 0 |
| K935309 | LUNG DIFFUSION | Acetylene Gas Co. | 1994-09-27 | 329 | 0 |
| K921306 | ARGIS PULMONARY FUNCTION TESTING SYSTEM | Med Science | 1993-06-25 | 464 | 0 |
| K915833 | SENSORMEDICS MODEL 2600 PEDIATRIC PULMOONARY CART | Sensor Medics Corp. | 1992-12-02 | 344 | 0 |
| K915686 | MODEL 2900 METABOLIC MEASUREMENT CART | Sensor Medics Corp. | 1992-12-01 | 347 | 0 |
| K913681 | MULTISPIRO-BREEZE | Multispiro, Inc. | 1992-07-02 | 318 | 0 |
| K905480 | SPIROSCOPE | Grandcor Medical Systems | 1991-05-06 | 151 | 0 |
| K900696 | BIORE CP-100 CARDIOPULMONARY MONITOR | Bicore Monitoring Systems | 1990-11-29 | 289 | 0 |
| K895963 | MODIFIED STAR CALC | Infrasonics Corp. | 1990-03-16 | 156 | 0 |
| K893845 | PEDS WATER FILLED CATHETER/TRANSDUCER SYSTEM | Medical Associated Services, Inc. | 1989-10-27 | 155 | 0 |
| K894839 | OS-1 OCCLUSION SYSTEM - 1 | Medical, Inc. | 1989-10-24 | 85 | 0 |
| K892670 | PHYSIO-DYNE EASI (EASY ANALOG SAMPLING INTERFACE) | Physio-Dyne Instrument Corp. | 1989-09-22 | 162 | 0 |
| K892121 | SPIRO-LINK REAL TIME SPIROMETRY SYSTEM | Biocom Intl., Inc. | 1989-06-16 | 77 | 0 |
| K881235 | Q-PLEX 1 | Quinton, Inc. | 1989-03-31 | 374 | 0 |
| K883732 | ARGIS PULMONARY FUNCTION TESTING SYSTEM | Advanced Signal Processing, Inc. | 1989-03-09 | 190 | 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