Product Code: BZC FDA class 2 21 CFR 868.1880

Calculator, Pulmonary Function Data

Anesthesiology

The Calculator, Pulmonary Function Data is a device or software tool that processes raw spirometric and respiratory measurements to derive and display calculated pulmonary function parameters for clinical assessment. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is BZC, regulated under 21 CFR 868.1880 in the Anesthesiology specialty. This device is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: BZC
Device Class: FDA class 2
Regulation Number: 868.1880
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 90 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K240293	STS	Sep 17, 2024	Substantially Equivalent	TechboPulm, Ltd.
K183567	Vyntus/SentrySuite Product Line	Aug 23, 2019	Substantially Equivalent	Vyaire Medical
K190853	Vyntus BODY	Aug 16, 2019	Substantially Equivalent	Vyaire Medical Inc.
K181524	Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART	Nov 30, 2018	Substantially Equivalent	Vyaire Medical, Inc.
K162515	COSMED K5 Wearable Metabolic Technology	Jun 20, 2017	Substantially Equivalent	COSMED S.r.l.
K161295	MiniBox +	Oct 21, 2016	Substantially Equivalent	PULMONE ADVANCED MEDICAL DEVICES, LTD
K150810	Vyntus / SentrySuite Product Line	Aug 14, 2015	Substantially Equivalent	CareFusion Germany 234 GmbH
K133925	VYNTUS/ SENTRYSUITE PRODUCT LINE	Aug 22, 2014	Substantially Equivalent	CAREFUSION GERMANY 234 GMBH
K133051	PULMONE MINIBOX PFT TM	May 02, 2014	Substantially Equivalent	PULMONE ADVANCED MEDICAL DEVICES, LTD
K102047	LCI OPTION FOR INNOCOR	Nov 01, 2011	Substantially Equivalent	INNOVISION A/S
K072323	MASTERSCREEN & OXYCON CPX	Oct 10, 2007	Substantially Equivalent	VIASYS HEALTHCARE GMBH
K052328	ZAN LUNG-FUNCTION LAB	Dec 22, 2005	Substantially Equivalent	ZAN MESSGERATE GMBH
K040698	MASTERSCREEN CPX AND OXYCON CPX	Apr 07, 2004	Substantially Equivalent	VIASYS HEALTHCARE GMBH
K023120	OXYCON MOBILE	Nov 12, 2003	Substantially Equivalent	ERICH JAEGER GMBH
K011344	INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, MODEL 004400	May 17, 2002	Substantially Equivalent	COLLINS MEDICAL, INC.
K001631	CORTEX METAMAX	Feb 22, 2001	Substantially Equivalent	CORTEX BIOPHYSIK GMBH
K001174	COSMED QUARK	Jan 11, 2001	Substantially Equivalent	COSMED S.R.L.
K001502	AEROSOL PROVOCATION SYSTEM APS PRO, MODEL APS PRO	Jul 12, 2000	Substantially Equivalent	ERICH JAEGER GMBH
K992214	OXYCON PRO	Feb 22, 2000	Substantially Equivalent	ERICH JAEGER B.V.
K982499	COSMO PLUS WITH NICO, MODEL 8200	Oct 16, 1998	Substantially Equivalent	NOVAMETRIX MEDICAL SYSTEMS, INC.
K982487	CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MONITOR METEOR 100, CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MO	Oct 14, 1998	Substantially Equivalent	CARDIOPULMONARY TECHNOLOGIES, INC.
K970840	INTELLIFLOW RESPIRATORY ANALYZER	Nov 26, 1997	Substantially Equivalent	SIMTEC, INC.
K963373	COSMED K4	Sep 10, 1997	Substantially Equivalent	COSMED S.R.L.
K964360	VENT(VENTCHECK) HANDHELD RESPIRATORY/MECHANICS MONITOR MODEL 101	Apr 04, 1997	Substantially Equivalent	NOVAMETRIX MEDICAL SYSTEMS, INC.
K954730	BENCHMARK TRANSFER TEST	Apr 01, 1997	Substantially Equivalent	P.K. MORGAN LTD.
K964939	THE PORTABLE FAMILY - MEDI-FACTS DX1 PORTABLE LITE AND DX1 PORTABLE PLUS	Mar 06, 1997	Substantially Equivalent	CREATIVE BIOMEDICS, INC.
K963380	CO 2 SMO PLUS	Jan 22, 1997	Substantially Equivalent	NOVAMETRIX MEDICAL SYSTEMS, INC.
K960121	AUTOLINK BODY PLETHYSMOGRAPH	Jan 09, 1997	Substantially Equivalent	P.K. MORGAN LTD.
K953990	TRANSFLOW TEST	Dec 09, 1996	Substantially Equivalent	P.K. MORGAN LTD.
K960831	VENTRAK RMMS 1550	May 29, 1996	Substantially Equivalent	NOVAMETRIX MEDICAL SYSTEMS, INC.
K952542	ACKRAD ESOPHAGEAL BALLOON CATHETER SET	Apr 23, 1996	Substantially Equivalent	ACKRAD LABORATORIES
K946077	DIRECTIONAL CONTROL VALVES INFLATABLE BALLOON-TYPE AND CONTROLLERS	Sep 15, 1995	Substantially Equivalent	HANS RUDOLPH, INC.
K951157	DX1-PORTABLE	Aug 11, 1995	Substantially Equivalent	CREATIVE BIOMEDICS, INC.
K941843	MMS-2400	Jun 16, 1995	Substantially Equivalent	PARVO MEDICS, INC.
K945213	TEEN 100	May 25, 1995	Substantially Equivalent	AEROSPORT, INC.
K942864	LUNG DIFFUSION	Mar 03, 1995	Substantially Equivalent	NORDAN SMITH WELDING SUPPLIES
K935309	LUNG DIFFUSION	Sep 27, 1994	Substantially Equivalent	ACETYLENE GAS CO.
K921306	ARGIS PULMONARY FUNCTION TESTING SYSTEM	Jun 25, 1993	Substantially Equivalent	MED SCIENCE
K915833	SENSORMEDICS MODEL 2600 PEDIATRIC PULMOONARY CART	Dec 02, 1992	Substantially Equivalent	SENSORMEDICS CORP.
K915686	MODEL 2900 METABOLIC MEASUREMENT CART	Dec 01, 1992	Substantially Equivalent	SENSORMEDICS CORP.
K913681	MULTISPIRO-BREEZE	Jul 02, 1992	Substantially Equivalent	MULTISPIRO, INC.
K905480	SPIROSCOPE	May 06, 1991	Substantially Equivalent	GRANDCOR MEDICAL SYSTEMS
K900696	BIORE CP-100 CARDIOPULMONARY MONITOR	Nov 29, 1990	Substantially Equivalent	BICORE MONITORING SYSTEMS
K895963	MODIFIED STAR CALC	Mar 16, 1990	Substantially Equivalent	INFRASONICS CORP.
K893845	PEDS WATER FILLED CATHETER/TRANSDUCER SYSTEM	Oct 27, 1989	Substantially Equivalent	MEDICAL ASSOCIATED SERVICES, INC.
K894839	OS-1 OCCLUSION SYSTEM - 1	Oct 24, 1989	Substantially Equivalent	MEDICAL, INC.
K892670	PHYSIO-DYNE EASI (EASY ANALOG SAMPLING INTERFACE)	Sep 22, 1989	Substantially Equivalent	PHYSIO-DYNE INSTRUMENT CORP.
K892121	SPIRO-LINK REAL TIME SPIROMETRY SYSTEM	Jun 16, 1989	Substantially Equivalent	BIOCOM INTL., INC.
K881235	Q-PLEX 1	Mar 31, 1989	Substantially Equivalent	QUINTON, INC.
K883732	ARGIS PULMONARY FUNCTION TESTING SYSTEM	Mar 09, 1989	Substantially Equivalent	ADVANCED SIGNAL PROCESSING, INC.
K875027	STAR CALC	Aug 16, 1988	Substantially Equivalent	INFRASONICS CORP.
K861418	SPINNAKER	May 09, 1986	Substantially Equivalent	CYBERMEDIC, INC.
K860844	VISTA INTERFACE SYSSTEM	Apr 02, 1986	Substantially Equivalent	VACUMETRICS, INC.
K854626	COMPUMED PULMONARY FUNCTION ANALYZER MODEL 307B	Feb 28, 1986	Substantially Equivalent	COMPUMED, INC.
K853443	ALVEO-DIFFUSION TEST	Feb 21, 1986	Substantially Equivalent	ERICH JAEGER, INC.
K855070	SPIROMETER MODEL TS-200 SLZ 7541	Jan 30, 1986	Substantially Equivalent	TELEDYNE AVIONICS DIV. OF TELEDYNE
K852909	MVP - 6000	Nov 14, 1985	Substantially Equivalent	WATERS INSTRUMENTS, INC.
K851805	LPA-3 PRINTER	Jul 08, 1985	Substantially Equivalent	LIFE PRODUCTS, INC.
K843860	OXYSCREEN	Dec 27, 1984	Substantially Equivalent	ERICH JAEGER, INC.
K843852	APTA-BRONCHOSCREEN	Nov 01, 1984	Substantially Equivalent	ERICH JAEGER, INC.
K843848	AW TEST	Nov 01, 1984	Substantially Equivalent	ERICH JAEGER, INC.
K843849	PNEUMOSCREEN	Oct 16, 1984	Substantially Equivalent	ERICH JAEGER, INC.
K842760	LUNG ANALYZER CM-310	Jul 26, 1984	Substantially Equivalent	CYBERMEDIC, INC.
K840711	PULMONARY FUNCTION SYS-3000	Apr 02, 1984	Substantially Equivalent	MED-SCIENCE ELECTRONICS, INC.
K831778	RS-RESIDUAL VOLUME SYSTEM	Aug 31, 1983	Substantially Equivalent	WARREN E. COLLINS, INC.
K831777	COLLINS DS	Aug 31, 1983	Substantially Equivalent	WARREN E. COLLINS, INC.
K831779	COLLINS EAGLE II	Aug 26, 1983	Substantially Equivalent	WARREN E. COLLINS, INC.
K830954	ACOH WELLNESS TESTER	Jun 10, 1983	Substantially Equivalent	BRADLEY, CAMPBELL & CARNEY
K822986	PULMONARY FUNCTION LAB SYSTEM 1070	Nov 16, 1982	Substantially Equivalent	MEDICAL GRAPHICS CORP.
K812001	OSCILLAIRE	Aug 20, 1981	Substantially Equivalent	JONES MEDICAL INSTRUMENT CO.
K810751	PDS CARDIAC CALC. SOFTW. PROGR. #A3604AF	Apr 10, 1981	Substantially Equivalent	GENERAL ELECTRIC CO.
K802920	INSPIRON PULMONARY FUNCTION ANALYZER	Feb 23, 1981	Substantially Equivalent	C.R. BARD, INC.
K810243	SYSTEM 86 COMPUTERIZED LUNG VOL. SPIROME	Feb 12, 1981	Substantially Equivalent	CARDIO PULMONARY INSTRUMENTS
K810196	SYSTEM 84 COMPUTERIZED LUNG VOL. SPIROM	Feb 05, 1981	Substantially Equivalent	CARDIO PULMONARY INSTRUMENTS
K803255	AUTOMATED PULMONARY FUNCTION LABORATORY	Jan 28, 1981	Substantially Equivalent	CARDIO PULMONARY INSTRUMENTS
K802928	SPIROMETRIC COMPUTER #SC-10	Dec 17, 1980	Substantially Equivalent	CAVITRON CORP.
K802116	ANESTHESIA GAS MACHINE	Oct 03, 1980	Substantially Equivalent	PURITAN BENNETT CORP.
K801920	SYSTEM 80 COMPUTERIZED SPIROMETER	Oct 03, 1980	Substantially Equivalent	PULMONARY TESTING SYSTEMS
K801919	SYSTEM 88 COMPUTERIZED DIFFUSION ANALY	Oct 03, 1980	Substantially Equivalent	PULMONARY TESTING SYSTEMS
K801918	SYSTEM 82 COMPUTERIZED LUNG VO. SPIRO	Oct 03, 1980	Substantially Equivalent	PULMONARY TESTING SYSTEMS
K801497	INFANT VENTILATORY MEASUREMENT SYSTEM	Oct 03, 1980	Substantially Equivalent	MEDICAL GRAPHICS CORP.
K801597	PFT CALIBRATOR	Aug 04, 1980	Substantially Equivalent	SPITAL MEDICAL, INC.
K801526	SURVEYOR I, RESPIRATORY COMPUTER SYSTEM	Jul 21, 1980	Substantially Equivalent	THE DEVILBISS CO.
K801088	F.R.C. APPARATUS	Jun 17, 1980	Substantially Equivalent	HOGAN/COLOGNE ENT.
K800547	MEDISTOR III LUNG ANALYZER	Mar 25, 1980	Substantially Equivalent	CYBERMEDIC, INC.
K791503	VITALOGRAPH FUNCTION ANALYZER	Aug 16, 1979	Substantially Equivalent	VITALOGRAPH LTD.
K790185	MODEL V 4207 INTEGRATING PLUG-IN	Feb 16, 1979	Substantially Equivalent	ELECTRONICS FOR MEDICINE, INC.
K780328	PULMONARY FUNCTION TESTER, COMPUTERIZED	Mar 14, 1978	Substantially Equivalent	WARREN E. COLLINS, INC.
K780322	ANALYZER, PULMONARY FUNCTION	Mar 14, 1978	Substantially Equivalent	HOSPAL MEDICAL CORP.
K770532	PC-30 PULMONARY COMPUTER	Apr 05, 1977	Substantially Equivalent	CAVITRON CORP.

FEI Numbers

This FDA classification entry is associated with 32 FEI numbers. Click on an entry to view related FDA registrations.

1000271197: 56 registrations

1000334329: 4 registrations

1216677: 233 registrations

1220477: 911 registrations

1314417: 210 registrations

1416588: 1 registration

2023529: 10 registrations

2183022: 15 registrations

2433214: 10 registrations

2518422: 147 registrations

2995: 12 registrations

3000126629: 658 registrations

3000203066: 50 registrations

3002807167: 118 registrations

3003001596: 44 registrations

3003007937: 5 registrations

3003009503: 1 registration

3003263092: 14 registrations

3003630525: 3 registrations

3004213967: 136 registrations

3009077524: 178 registrations

3010320336: 2 registrations

3011269086: 2 registrations

3012528160: 30 registrations

3013500228: 47 registrations

3013596024: 49 registrations

3016701404: 34 registrations

3017935637: 1 registration

3018783526: 184 registrations

3023272766: 173 registrations

3033959233: 56 registrations

3036774597: 1 registration