Atlas FDA

BTY

63 FDA 510(k) clearances · Product code

106 daysmedian time to decision
315 days90th percentile
63clearances measured

FDA profile

Official device name
Calculator, Predicted Values, Pulmonary Function
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1890
Medical specialty
Anesthesiology
Flags
Third-party review eligible
Adverse events (MAUDE)
2000: 3 · 2001: 5 · 2003: 3 · 2004: 2 · 2015: 51 · 2016: 24
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Ascent Cardiorespiratory Diagnostic Software (K242809)Medical Graphics Corporation2024-10-17
SpiroSphere, SpiroSphereECG, CardioSphere (K223629)Eresearchtechnology GmbH2024-05-28
Pulmonary Function Tester, Model: A9 (K231561)Guangzhou Homesun Medical Technology Co., Ltd.2024-02-21
Virtus Metabolic Monitor (K222982)Virtus Technology Aps2023-06-23
Model 9100 PFT/DICO (K221030)Vitalograph Ireland, Ltd.2022-07-15
MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU (K202754)Eresearchtechnology GmbH2021-01-28
Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors (K190800)Cosmed Srl2020-02-06
Ascent Cardiorespiratory Diagnostic Software (K181912)Medical Graphics Corporation2019-04-12
SpiroSphere (K173937)Eresearchtechnology GmbH2019-02-15
EasyOne Pro Respiratory Analysis System (K161534)Ndd Medizintechnik AG2017-02-22
Shape-HF Cardiopulmonary Testing System (K150888)Shape Medical Systems, Inc.2016-01-21
SENTRYSUITE PRODUCT LINE (K122699)Carefusion Germany 234 GmbH2012-11-19
EASYONE PRO RESPIRATORY TESTING DEVICE (K120635)Ndd Medizitechnik AG2012-09-27
SENTRYSUITE PRODUCT LINE (K113813)Carefusion Germany 234 GmbH2012-05-10
SENTRYSUITE PRODUCT LINE (K111053)Carefusion Germany 234 GmbH2011-08-12
EASYONE PRO RESPIRATORY ANALYSIS SYSTEM (K091428)Ndd Medizitechnik AG2010-01-27
SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM (K090722)Shape Medical Systems, Inc.2009-03-31
MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT (K082539)Cardinal Health Germany 234 GmbH2008-12-02
VIP PULMONARY FUNCTION SYSTEM (K080510)Viasys Healthcare GmbH2008-08-20
FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT (K080734)Viasys Healthcare GmbH2008-06-26
MASTERSCREEN PNEUMO & MASTERSCOPE (K071753)Viasys Healthcare GmbH2007-08-14
MODIFICATION TO FLOWSCREEN (K062011)Viasys Healthcare GmbH2007-05-11
COSMED PONY FX (K040549)Cosmed Srl2004-09-28
SPIROSOFT (K031194)Viasys Healthcare GmbH2003-07-30
COSMED MICROQUARK (K020745)Cosmed Srl2003-01-02
METALYZER, MODEL 2; METALYZER, MODEL 3 (K993641)Cortex Biophysik GmbH2000-12-14
SPIRO PRO (K000648)Erich Jaeger GmbH2000-03-29
STATIC AND DYNAMIC COMPLIANCE, A RESPIRATORY MECHANICS OPTION FOR THE VMAX SERIES (K981366)Sensor Medics Corp.1998-10-30
MODIFICATION TO THE OXYCONALPHA (K980094)Erich Jaeger B.V.1998-07-28
DSXL DIFFUSION SPIROMETER (K961252)Inair , Ltd.1997-02-14
OXYCON-ALPHA (K942230)Mijnhardt B.V.1995-03-20
VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS (K942211)Sensor Medics Corp.1994-11-22
FLOWSCREEN (K932744)Erich Jaeger, Inc.1994-03-07
MASTER SCREEN PNUEMO (K933839)Erich Jaeger, Inc.1994-03-07
UPGRADED SPIROMETER ST-90 (K933511)Futuremed Div. of Future Impex Corp.1994-02-10
PFM PROFESSIONAL 7000 SPIROMETER (K932278)Advanced Medical Systems, Inc.1993-12-17
MODEL 508 PATIENT MONITOR (K921309)Criticare Systems, Inc.1993-12-17
VITALOGRAPH DATA STORAGE SPIROMETER (K930085)Vitalograph , Ltd.1993-07-26
CMD/DLCO DIAGNOSTIC SPIROMETER (K911358)Spirometrics, Inc.1991-07-22
EBS2605 INFANT HUGGER (K892705)Equilibrated Bio Systems, Inc.1989-10-27
MODELS PB950 AND PB960 DATALOOP AND SPIROLOOP (K894667)Pneumedics, Inc.1989-10-19
PULMONARY FORCED FLOW SYSTEM (PUFFS) (K883008)Medical Associated Services, Inc.1988-09-29
UPDATED MANUAL FOR PEDS - PULMONARY EVAL. & DIAG. (K881122)Medical Associated Services, Inc.1988-06-10
L.A.P. SPIROMETER (K864836)Timeter Instrument Corp.1987-03-06
PEDS PULMONARY EVALUATION & DIAGNOSTIC SYSTEM (K864087)Medical Associated Services, Inc.1986-11-07
SPIROLOOP-PULMONARY EXERCISE SYSTEM (K863087)Pneumedics, Inc.1986-10-27
ST-90 SPIRO ANALIZER (K861487)Future Impex Corp.1986-06-23
SPIROMETRY MODULE (K861486)Medical Graphics Corp.1986-05-19
SPIROMETER, MODEL TS-500 PART #SLZ7534 (K855068)Teledyne Avionics Div. of Teledyne1986-02-05
SPIROMETER TS-400 SLZ 7547 (K855069)Teledyne Avionics Div. of Teledyne1986-01-30
CUSTO VIT PULMONARY FUNCTION ANALYSIS SYSTEM (K854745)Versacor, Inc.1986-01-10
ELF (K853433)Cardio-Respiratory1985-11-29
SPIROMETRICS 2453 & SMI III (K850045)Spirometrics, Inc.1985-02-14
SPIROTECH 300 (K823771)Spirotech, Inc.1983-01-28
VITALOGRAPH PFT PRINTER (K823683)Vitalograph , Ltd.1983-01-21
INFORMED REMOTE FIELD UNIT MODEL IFM1000 (K821712)Burditt & Calkins-Siemens-Elema1982-07-26
PTT-200 TELEPHONIC PULMONARY TRANSMITT (K812849)Pharmaquest Corp.1981-12-03
PTT-200 PULMONARY RECEIVER/MICROPROCES (K812850)Pharmaquest Corp.1981-12-03
PFT SCREENER (SYSTEM 1100) (K812792)Medical Graphics Corp.1981-11-27
ELECTRONIC SPIROMETER MODEL MFR-8100 (K810712)Nihon Kohden America, Inc.1981-03-24
APEXLINE OF PULMONARY FUNCT. INSTRUM. (K803053)Warren E. Collins, Inc.1980-12-22
MEDISTOR II (K790579)Cybermedic, Inc.1979-04-04
PULMONARY FUNCTION TESTER (K780584)Warren E. Collins, Inc.1978-05-16

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