Atlas FDA

BZC

90 FDA 510(k) clearances · Product code

102 daysmedian time to decision
374 days90th percentile
90clearances measured

FDA profile

Official device name
Calculator, Pulmonary Function Data
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1880
Medical specialty
Anesthesiology
Flags
Third-party review eligible
Adverse events (MAUDE)
1997: 2 · 1998: 1 · 1999: 1 · 2005: 1 · 2006: 2 · 2008: 3
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
STS (K240293)Techbopulm, Ltd.2024-09-17
Vyntus/SentrySuite Product Line (K183567)Vyaire Medical2019-08-23
Vyntus BODY (K190853)Vyaire Medical, Inc.2019-08-16
Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART (K181524)Vyaire Medical, Inc.2018-11-30
COSMED K5 Wearable Metabolic Technology (K162515)Cosmed Srl2017-06-20
MiniBox + (K161295)Pulmone Advanced Medical Devices, Ltd.2016-10-21
Vyntus / SentrySuite Product Line (K150810)Carefusion Germany 234 GmbH2015-08-14
VYNTUS/ SENTRYSUITE PRODUCT LINE (K133925)Carefusion Germany 234 GmbH2014-08-22
PULMONE MINIBOX PFT TM (K133051)Pulmone Advanced Medical Devices, Ltd.2014-05-02
LCI OPTION FOR INNOCOR (K102047)Innovision A/S2011-11-01
MASTERSCREEN & OXYCON CPX (K072323)Viasys Healthcare GmbH2007-10-10
ZAN LUNG-FUNCTION LAB (K052328)Zan Messgerate GmbH2005-12-22
MASTERSCREEN CPX AND OXYCON CPX (K040698)Viasys Healthcare GmbH2004-04-07
OXYCON MOBILE (K023120)Erich Jaeger GmbH2003-11-12
INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, MODEL 004400 (K011344)Collins Medical, Inc.2002-05-17
CORTEX METAMAX (K001631)Cortex Biophysik GmbH2001-02-22
COSMED QUARK (K001174)Cosmed Srl2001-01-11
AEROSOL PROVOCATION SYSTEM APS PRO, MODEL APS PRO (K001502)Erich Jaeger GmbH2000-07-12
OXYCON PRO (K992214)Erich Jaeger B.V.2000-02-22
COSMO PLUS WITH NICO, MODEL 8200 (K982499)Novametrix Medical Systems, Inc.1998-10-16
CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MONITOR METEOR 100, CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MO (K982487)Cardiopulmonary Technologies, Inc.1998-10-14
INTELLIFLOW RESPIRATORY ANALYZER (K970840)Simtec, Inc.1997-11-26
COSMED K4 (K963373)Cosmed Srl1997-09-10
VENT(VENTCHECK) HANDHELD RESPIRATORY/MECHANICS MONITOR MODEL 101 (K964360)Novametrix Medical Systems, Inc.1997-04-04
BENCHMARK TRANSFER TEST (K954730)P.K. Morgan , Ltd.1997-04-01
THE PORTABLE FAMILY - MEDI-FACTS DX1 PORTABLE LITE AND DX1 PORTABLE PLUS (K964939)Creative Biomedics, Inc.1997-03-06
CO 2 SMO PLUS (K963380)Novametrix Medical Systems, Inc.1997-01-22
AUTOLINK BODY PLETHYSMOGRAPH (K960121)P.K. Morgan , Ltd.1997-01-09
TRANSFLOW TEST (K953990)P.K. Morgan , Ltd.1996-12-09
VENTRAK RMMS 1550 (K960831)Novametrix Medical Systems, Inc.1996-05-29
ACKRAD ESOPHAGEAL BALLOON CATHETER SET (K952542)Ackrad Laboratories1996-04-23
DIRECTIONAL CONTROL VALVES INFLATABLE BALLOON-TYPE AND CONTROLLERS (K946077)Hans Rudolph, Inc.1995-09-15
DX1-PORTABLE (K951157)Creative Biomedics, Inc.1995-08-11
MMS-2400 (K941843)Parvo Medics, Inc.1995-06-16
TEEN 100 (K945213)Aerosport, Inc.1995-05-25
LUNG DIFFUSION (K942864)Nordan Smith Welding Supplies1995-03-03
LUNG DIFFUSION (K935309)Acetylene Gas Co.1994-09-27
ARGIS PULMONARY FUNCTION TESTING SYSTEM (K921306)Med Science1993-06-25
SENSORMEDICS MODEL 2600 PEDIATRIC PULMOONARY CART (K915833)Sensor Medics Corp.1992-12-02
MODEL 2900 METABOLIC MEASUREMENT CART (K915686)Sensor Medics Corp.1992-12-01
MULTISPIRO-BREEZE (K913681)Multispiro, Inc.1992-07-02
SPIROSCOPE (K905480)Grandcor Medical Systems1991-05-06
BIORE CP-100 CARDIOPULMONARY MONITOR (K900696)Bicore Monitoring Systems1990-11-29
MODIFIED STAR CALC (K895963)Infrasonics Corp.1990-03-16
PEDS WATER FILLED CATHETER/TRANSDUCER SYSTEM (K893845)Medical Associated Services, Inc.1989-10-27
OS-1 OCCLUSION SYSTEM - 1 (K894839)Medical, Inc.1989-10-24
PHYSIO-DYNE EASI (EASY ANALOG SAMPLING INTERFACE) (K892670)Physio-Dyne Instrument Corp.1989-09-22
SPIRO-LINK REAL TIME SPIROMETRY SYSTEM (K892121)Biocom Intl., Inc.1989-06-16
Q-PLEX 1 (K881235)Quinton, Inc.1989-03-31
ARGIS PULMONARY FUNCTION TESTING SYSTEM (K883732)Advanced Signal Processing, Inc.1989-03-09
STAR CALC (K875027)Infrasonics Corp.1988-08-16
SPINNAKER (K861418)Cybermedic, Inc.1986-05-09
VISTA INTERFACE SYSSTEM (K860844)Vacumetrics, Inc.1986-04-02
COMPUMED PULMONARY FUNCTION ANALYZER MODEL 307B (K854626)Compumed, Inc.1986-02-28
ALVEO-DIFFUSION TEST (K853443)Erich Jaeger, Inc.1986-02-21
SPIROMETER MODEL TS-200 SLZ 7541 (K855070)Teledyne Avionics Div. of Teledyne1986-01-30
MVP - 6000 (K852909)Waters Instruments, Inc.1985-11-14
LPA-3 PRINTER (K851805)Life Products, Inc.1985-07-08
OXYSCREEN (K843860)Erich Jaeger, Inc.1984-12-27
APTA-BRONCHOSCREEN (K843852)Erich Jaeger, Inc.1984-11-01
AW TEST (K843848)Erich Jaeger, Inc.1984-11-01
PNEUMOSCREEN (K843849)Erich Jaeger, Inc.1984-10-16
LUNG ANALYZER CM-310 (K842760)Cybermedic, Inc.1984-07-26
PULMONARY FUNCTION SYS-3000 (K840711)Med-Science Electronics, Inc.1984-04-02
COLLINS DS (K831777)Warren E. Collins, Inc.1983-08-31
RS-RESIDUAL VOLUME SYSTEM (K831778)Warren E. Collins, Inc.1983-08-31
COLLINS EAGLE II (K831779)Warren E. Collins, Inc.1983-08-26
ACOH WELLNESS TESTER (K830954)Bradley, Campbell & Carney1983-06-10
PULMONARY FUNCTION LAB SYSTEM 1070 (K822986)Medical Graphics Corp.1982-11-16
OSCILLAIRE (K812001)Jones Medical Instrument Co.1981-08-20
PDS CARDIAC CALC. SOFTW. PROGR. #A3604AF (K810751)General Electric Co.1981-04-10
INSPIRON PULMONARY FUNCTION ANALYZER (K802920)C.R. Bard, Inc.1981-02-23
SYSTEM 86 COMPUTERIZED LUNG VOL. SPIROME (K810243)Cardio Pulmonary Instruments1981-02-12
SYSTEM 84 COMPUTERIZED LUNG VOL. SPIROM (K810196)Cardio Pulmonary Instruments1981-02-05
AUTOMATED PULMONARY FUNCTION LABORATORY (K803255)Cardio Pulmonary Instruments1981-01-28
SPIROMETRIC COMPUTER #SC-10 (K802928)Cavitron Corp.1980-12-17
SYSTEM 80 COMPUTERIZED SPIROMETER (K801920)Pulmonary Testing Systems1980-10-03
INFANT VENTILATORY MEASUREMENT SYSTEM (K801497)Medical Graphics Corp.1980-10-03
SYSTEM 88 COMPUTERIZED DIFFUSION ANALY (K801919)Pulmonary Testing Systems1980-10-03
SYSTEM 82 COMPUTERIZED LUNG VO. SPIRO (K801918)Pulmonary Testing Systems1980-10-03
ANESTHESIA GAS MACHINE (K802116)Puritan Bennett Corp.1980-10-03
PFT CALIBRATOR (K801597)Spital Medical, Inc.1980-08-04
SURVEYOR I, RESPIRATORY COMPUTER SYSTEM (K801526)The Devilbiss Co.1980-07-21
F.R.C. APPARATUS (K801088)Hogan/Cologne Ent.1980-06-17
MEDISTOR III LUNG ANALYZER (K800547)Cybermedic, Inc.1980-03-25
VITALOGRAPH FUNCTION ANALYZER (K791503)Vitalograph , Ltd.1979-08-16
MODEL V 4207 INTEGRATING PLUG-IN (K790185)Electronics For Medicine, Inc.1979-02-16
PULMONARY FUNCTION TESTER, COMPUTERIZED (K780328)Warren E. Collins, Inc.1978-03-14
ANALYZER, PULMONARY FUNCTION (K780322)Hospal Medical Corp.1978-03-14
PC-30 PULMONARY COMPUTER (K770532)Cavitron Corp.1977-04-05

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