BTY · Class II · 21 CFR 868.1890

FDA Product Code BTY: Calculator, Predicted Values, Pulmonary Function

Leading manufacturers include Viasys Healthcare GmbH, Carefusion Germany 234 GmbH and Eresearchtechnology GmbH.

64
Total
64
Cleared
159d
Avg days
1978
Since
Declining activity - 2 submissions in the last 2 years vs 3 in the prior period
Review times improving: avg 118d recently vs 160d historically

FDA 510(k) Cleared Calculator, Predicted Values, Pulmonary Function Devices (Product Code BTY)

64 devices
1–24 of 64
Cleared Aug 20, 2026
CPETWise Platform
K260242
Medibyt , Ltd.
Anesthesiology · 206d
Cleared Oct 17, 2024
Ascent Cardiorespiratory Diagnostic Software
K242809
Medical Graphics Corporation
Anesthesiology · 30d
Cleared May 28, 2024
SpiroSphere, SpiroSphereECG, CardioSphere
K223629
Eresearchtechnology GmbH
Cardiovascular · 540d
Cleared Feb 21, 2024
Pulmonary Function Tester, Model: A9
K231561
Guangzhou Homesun Medical Technology Co., Ltd.
Anesthesiology · 266d
Cleared Jun 23, 2023
Virtus Metabolic Monitor
K222982
Virtus Technology Aps
Anesthesiology · 268d
Cleared Jul 15, 2022
Model 9100 PFT/DICO
K221030
Vitalograph (Ireland) , Ltd.
Anesthesiology · 99d
Cleared Jan 28, 2021
MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU
K202754
Eresearchtechnology GmbH
Anesthesiology · 129d
Cleared Feb 06, 2020
Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors
K190800
Cosmed Srl
Anesthesiology · 315d
Cleared Apr 12, 2019
Ascent Cardiorespiratory Diagnostic Software
K181912
Medical Graphics Corporation
Anesthesiology · 269d
Cleared Feb 15, 2019
SpiroSphere
K173937
Eresearchtechnology GmbH
Anesthesiology · 416d
Cleared Feb 22, 2017
EasyOne Pro Respiratory Analysis System
K161534
Ndd Medizintechnik AG
Anesthesiology · 264d
Cleared Jan 21, 2016
Shape-HF Cardiopulmonary Testing System
K150888
Shape Medical Systems, Inc.
Anesthesiology · 294d
Cleared Nov 19, 2012
SENTRYSUITE PRODUCT LINE
K122699
Carefusion Germany 234 GmbH
Anesthesiology · 76d
Cleared Sep 27, 2012
EASYONE PRO RESPIRATORY TESTING DEVICE
K120635
Ndd Medizitechnik AG
Anesthesiology · 210d
Cleared May 10, 2012
SENTRYSUITE PRODUCT LINE
K113813
Carefusion Germany 234 GmbH
Anesthesiology · 139d
Cleared Aug 12, 2011
SENTRYSUITE PRODUCT LINE
K111053
Carefusion Germany 234 GmbH
Anesthesiology · 119d
Cleared Jan 27, 2010
EASYONE PRO RESPIRATORY ANALYSIS SYSTEM
K091428
Ndd Medizitechnik AG
Anesthesiology · 258d
Cleared Mar 31, 2009
SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM
K090722
Shape Medical Systems, Inc.
Anesthesiology · 12d
Cleared Dec 02, 2008
MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT
K082539
Cardinal Health Germany 234 GmbH
Anesthesiology · 91d
Cleared Aug 20, 2008
VIP PULMONARY FUNCTION SYSTEM
K080510
Viasys Healthcare GmbH
Anesthesiology · 177d
Cleared Jun 26, 2008
FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT
K080734
Viasys Healthcare GmbH
Anesthesiology · 104d
Cleared Aug 14, 2007
MASTERSCREEN PNEUMO & MASTERSCOPE
K071753
Viasys Healthcare GmbH
Anesthesiology · 47d
Cleared May 11, 2007
MODIFICATION TO FLOWSCREEN
K062011
Viasys Healthcare GmbH
Anesthesiology · 298d
Cleared Jan 02, 2003
COSMED MICROQUARK
K020745
Cosmed Srl
Anesthesiology · 301d

About Product Code BTY - Regulatory Context

510(k) Submission Activity

64 total 510(k) submissions under product code BTY since 1978, with 64 receiving FDA clearance (average review time: 159 days).

Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 3 in the prior period.

FDA 510(k) Review Time - BTY Product Code

Recent submissions under BTY have taken an average of 118 days to reach a decision - down from 160 days historically, suggesting improved FDA processing for this classification.

BTY devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →