Product Code: BTY FDA class 2 21 CFR 868.1890

Calculator, Predicted Values, Pulmonary Function

Anesthesiology

The Calculator, Predicted Values, Pulmonary Function is a device or software tool used to calculate expected or normal pulmonary function values based on patient demographics such as age, height, sex, and ethnicity, serving as a reference for interpreting spirometry results. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is BTY, regulated under 21 CFR 868.1890 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

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Basic Information

Product Code: BTY
Device Class: FDA class 2
Regulation Number: 868.1890
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 63 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K242809	Ascent Cardiorespiratory Diagnostic Software	Oct 17, 2024	Substantially Equivalent	Medical Graphics Corporation
K223629	SpiroSphere, SpiroSphereECG, CardioSphere	May 28, 2024	Substantially Equivalent	Eresearchtechnology GmbH
K231561	Pulmonary Function Tester, Model: A9	Feb 21, 2024	Substantially Equivalent	Guangzhou Homesun Medical Technology Co., Ltd.
K222982	Virtus Metabolic Monitor	Jun 23, 2023	Substantially Equivalent	Virtus Technology Aps
K221030	Model 9100 PFT/DICO	Jul 15, 2022	Substantially Equivalent	Vitalograph Ireland, Ltd.
K202754	MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU	Jan 28, 2021	Substantially Equivalent	Eresearchtechnology GmbH
K190800	Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors	Feb 06, 2020	Substantially Equivalent	Cosmed Srl
K181912	Ascent Cardiorespiratory Diagnostic Software	Apr 12, 2019	Substantially Equivalent	Medical Graphics Corporation
K173937	SpiroSphere	Feb 15, 2019	Substantially Equivalent	Eresearchtechnology GmbH
K161534	EasyOne Pro Respiratory Analysis System	Feb 22, 2017	Substantially Equivalent	Ndd Medizintechnik AG
K150888	Shape-HF Cardiopulmonary Testing System	Jan 21, 2016	Substantially Equivalent	Shape Medical Systems, Inc.
K122699	SENTRYSUITE PRODUCT LINE	Nov 19, 2012	Substantially Equivalent	Carefusion Germany 234 GmbH
K120635	EASYONE PRO RESPIRATORY TESTING DEVICE	Sep 27, 2012	Substantially Equivalent	Ndd Medizitechnik AG
K113813	SENTRYSUITE PRODUCT LINE	May 10, 2012	Substantially Equivalent	Carefusion Germany 234 GmbH
K111053	SENTRYSUITE PRODUCT LINE	Aug 12, 2011	Substantially Equivalent	Carefusion Germany 234 GmbH
K091428	EASYONE PRO RESPIRATORY ANALYSIS SYSTEM	Jan 27, 2010	Substantially Equivalent	Ndd Medizitechnik AG
K090722	SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM	Mar 31, 2009	Substantially Equivalent	Shape Medical Systems, Inc.
K082539	MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT	Dec 02, 2008	Substantially Equivalent	Cardinal Health Germany 234 GmbH
K080510	VIP PULMONARY FUNCTION SYSTEM	Aug 20, 2008	Substantially Equivalent	Viasys Healthcare GmbH
K080734	FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT	Jun 26, 2008	Substantially Equivalent	Viasys Healthcare GmbH
K071753	MASTERSCREEN PNEUMO & MASTERSCOPE	Aug 14, 2007	Substantially Equivalent	Viasys Healthcare GmbH
K062011	MODIFICATION TO FLOWSCREEN	May 11, 2007	Substantially Equivalent	Viasys Healthcare GmbH
K040549	COSMED PONY FX	Sep 28, 2004	Substantially Equivalent	Cosmed Srl
K031194	SPIROSOFT	Jul 30, 2003	Substantially Equivalent	Viasys Healthcare GmbH
K020745	COSMED MICROQUARK	Jan 02, 2003	Substantially Equivalent	Cosmed Srl
K993641	METALYZER, MODEL 2; METALYZER, MODEL 3	Dec 14, 2000	Substantially Equivalent	Cortex Biophysik GmbH
K000648	SPIRO PRO	Mar 29, 2000	Substantially Equivalent	Erich Jaeger GmbH
K981366	STATIC AND DYNAMIC COMPLIANCE, A RESPIRATORY MECHANICS OPTION FOR THE VMAX SERIES	Oct 30, 1998	Substantially Equivalent	Sensor Medics Corp.
K980094	MODIFICATION TO THE OXYCONALPHA	Jul 28, 1998	Substantially Equivalent	Erich Jaeger B.V.
K961252	DSXL DIFFUSION SPIROMETER	Feb 14, 1997	Substantially Equivalent	Inair , Ltd.
K942230	OXYCON-ALPHA	Mar 20, 1995	Substantially Equivalent	Mijnhardt B.V.
K942211	VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS	Nov 22, 1994	Substantially Equivalent	Sensor Medics Corp.
K933839	MASTER SCREEN PNUEMO	Mar 07, 1994	Substantially Equivalent	Erich Jaeger, Inc.
K932744	FLOWSCREEN	Mar 07, 1994	Substantially Equivalent	Erich Jaeger, Inc.
K933511	UPGRADED SPIROMETER ST-90	Feb 10, 1994	Substantially Equivalent	Futuremed Div. of Future Impex Corp.
K932278	PFM PROFESSIONAL 7000 SPIROMETER	Dec 17, 1993	Substantially Equivalent	Advanced Medical Systems, Inc.
K921309	MODEL 508 PATIENT MONITOR	Dec 17, 1993	Substantially Equivalent	Criticare Systems, Inc.
K930085	VITALOGRAPH DATA STORAGE SPIROMETER	Jul 26, 1993	Substantially Equivalent	Vitalograph , Ltd.
K911358	CMD/DLCO DIAGNOSTIC SPIROMETER	Jul 22, 1991	Substantially Equivalent	Spirometrics, Inc.
K892705	EBS2605 INFANT HUGGER	Oct 27, 1989	Substantially Equivalent	Equilibrated Bio Systems, Inc.
K894667	MODELS PB950 AND PB960 DATALOOP AND SPIROLOOP	Oct 19, 1989	Substantially Equivalent	Pneumedics, Inc.
K883008	PULMONARY FORCED FLOW SYSTEM (PUFFS)	Sep 29, 1988	Substantially Equivalent	Medical Associated Services, Inc.
K881122	UPDATED MANUAL FOR PEDS - PULMONARY EVAL. & DIAG.	Jun 10, 1988	Substantially Equivalent	Medical Associated Services, Inc.
K864836	L.A.P. SPIROMETER	Mar 06, 1987	Substantially Equivalent	Timeter Instrument Corp.
K864087	PEDS PULMONARY EVALUATION & DIAGNOSTIC SYSTEM	Nov 07, 1986	Substantially Equivalent	Medical Associated Services, Inc.
K863087	SPIROLOOP-PULMONARY EXERCISE SYSTEM	Oct 27, 1986	Substantially Equivalent	Pneumedics, Inc.
K861487	ST-90 SPIRO ANALIZER	Jun 23, 1986	Substantially Equivalent	Future Impex Corp.
K861486	SPIROMETRY MODULE	May 19, 1986	Substantially Equivalent	Medical Graphics Corp.
K855068	SPIROMETER, MODEL TS-500 PART #SLZ7534	Feb 05, 1986	Substantially Equivalent	Teledyne Avionics Div. of Teledyne
K855069	SPIROMETER TS-400 SLZ 7547	Jan 30, 1986	Substantially Equivalent	Teledyne Avionics Div. of Teledyne
K854745	CUSTO VIT PULMONARY FUNCTION ANALYSIS SYSTEM	Jan 10, 1986	Substantially Equivalent	Versacor, Inc.
K853433	ELF	Nov 29, 1985	Substantially Equivalent	Cardio-Respiratory
K850045	SPIROMETRICS 2453 & SMI III	Feb 14, 1985	Substantially Equivalent	Spirometrics, Inc.
K823771	SPIROTECH 300	Jan 28, 1983	Substantially Equivalent	Spirotech, Inc.
K823683	VITALOGRAPH PFT PRINTER	Jan 21, 1983	Substantially Equivalent	Vitalograph , Ltd.
K821712	INFORMED REMOTE FIELD UNIT MODEL IFM1000	Jul 26, 1982	Substantially Equivalent	Burditt & Calkins-Siemens-Elema
K812850	PTT-200 PULMONARY RECEIVER/MICROPROCES	Dec 03, 1981	Substantially Equivalent	Pharmaquest Corp.
K812849	PTT-200 TELEPHONIC PULMONARY TRANSMITT	Dec 03, 1981	Substantially Equivalent	Pharmaquest Corp.
K812792	PFT SCREENER (SYSTEM 1100)	Nov 27, 1981	Substantially Equivalent	Medical Graphics Corp.
K810712	ELECTRONIC SPIROMETER MODEL MFR-8100	Mar 24, 1981	Substantially Equivalent	Nihon Kohden America, Inc.
K803053	APEXLINE OF PULMONARY FUNCT. INSTRUM.	Dec 22, 1980	Substantially Equivalent	Warren E. Collins, Inc.
K790579	MEDISTOR II	Apr 04, 1979	Substantially Equivalent	Cybermedic, Inc.
K780584	PULMONARY FUNCTION TESTER	May 16, 1978	Substantially Equivalent	Warren E. Collins, Inc.