BTY · Class II · 21 CFR 868.1890

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

Leading manufacturers include Eresearchtechnology GmbH, Medical Graphics Corporation and Cosmed Srl.

63
Total
63
Cleared
158d
Avg days
1978
Since
Declining activity - 1 submissions in the last 2 years vs 4 in the prior period
Review times improving: avg 30d recently vs 160d historically

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

63 devices
1–24 of 63
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 Mar 24, 1981
ELECTRONIC SPIROMETER MODEL MFR-8100
K810712
Nihon Kohden America, Inc.
Anesthesiology · 7d

About Product Code BTY - Regulatory Context

510(k) Submission Activity

63 total 510(k) submissions under product code BTY since 1978, with 63 receiving FDA clearance (average review time: 158 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 4 in the prior period.

FDA 510(k) Review Time - BTY Product Code

Recent submissions under BTY have taken an average of 30 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 →